Walnut

Subscribe to RSS Feed for recent updates
Subscribe to RSS Feed for recent updates

YANA - YOU ARE NOT ALONE NOW

PROSTATE CANCER SUPPORT SITE

 

SURVIVOR STORIES  :  DISCUSSION FORUM  :  WIVES & PARTNERS  :  TELL YOUR STORY  :  UPDATE YOUR STORY  :  DONATIONS  :  TROOP-C

YANA HOME PAGE  :  DON'T PANIC  :  GOOD NEWS!  :  DIAGNOSIS  :  SURVIVING  :  TREATMENT CHOICES  :  RESOURCES  :  ABOUT US  :  MAIL US

 

This is the last of five steps in a series aimed at helping newly diagnosed people understand some of the basics of a complex disease. The sequence of the first four steps is DON'T PANIC : GOOD NEWS! : DIAGNOSIS : SURVIVING. If you missed any of these first four steps, our recommendation is to go back and follow them in sequence. Doing this will help you interpret some of the information about the treatment choices.

The notion of choosing your own treatment for a medical problem is completely foreign to most people. If you have a broken arm you expect it will be set in plaster; if you have a child with acute appendicitis you expect they will have an appendectomy. That is what the normal course of events is. There is no real discussion and often no explanation. This is not the case with prostate cancer. There is a range of options and these are set out below. It is in your own interest to research them all. This page is followed by a page titled RESOURCES which summarizes some of the sites, other than this one, where you might find additional useful information. That page is linked from this page.

CHOOSING A TREATMENT

THE BASICS

The Golden Rule. The Golden Rule of prostate cancer is simple: THERE ARE NO RULES. This lack of rules creates uncertainty. Uncertainty is difficult to deal with but is unavoidable.

Every Choice Has Consequences. No matter which choice is made, there are consequences. Some are good, some less so. Much depends on the specific circumstances and few are accurately predictable.

No Good Data. There is a lack of really good information about the outcomes and consequences of the treatment options. No one can guarantee that what worked for one man will necessarily work for others. This makes it very difficult to choose which path to follow.

Status Before Strategy. It is best to gather all possible information about a diagnosis and all options available before making a choice. There are many options; all should be considered.

Choose The Best Team: It may seem blindingly obvious, but the skill and track record of the people chosen to advise, monitor and carry out a procedure are the best predictors of a good result. There is an understandable bias in the recommendation for treatment which must be recognized. For the same diagnosis, surgeons will tend to recommend surgery; radiologists will tend to recommend radiation.

CONSEQUENCES OF CHOICES

There are consequences attached to all choices. Some are good consequences - the best being there is no sign of the cancer after the procedure. Some are not so good - these are usually referred to as side effects or morbidity. Impotence [the inability to have an erection] and incontinence [the inability to control your bladder or your bowel] are the ones that concern men the most. A brief summary of potential consequences is shown for all the treatment options listed on this site. These are shown under the header for each treatment choice together with the other relevant information. One of the consequences that is frequently overlooked or not discussed is depression. This subject is dealt with in this piece - DEPRESSION - REAL OR INDUCED?

It is important to understand that the consequences of any choice are variable. There are some actions that can reduce the potential severity of the negative consequences, but sometimes a combination of the site of a tumor, the skill of a doctor or even the attitude of the man undergoing the therapy can affect the outcome. It is also often difficult to distinguish clearly between the consequences attached to the choice made and the consequences of aging.

What data there is shows very little difference in outcomes and consequences for the majority of men who have what is termed low risk or very low risk tumors, no matter what path they choose. There are clear definitions of low risk or very low risk tumors in the NCCN GUIDELINES FOR PATIENTS - PROSTATE CANCER.

NO GOOD DATA

Most men are surprised to find that there are no clear comparative guides as to outcome of the various choices that might be available to them. There are many reasons for this lack of data: some are more acceptable than others. But whatever the reasons, the data is not there. To add to the confusion, new studies are published frequently. Some of these seem to contradict other studies and some are interpreted by the media in ways that ensure headlines rather than accuracy.

This lack of reliable, relevant data makes it extremely difficult to make an informed decision as to which of the many treatment options is 'best' for you. Effective Health Care published an excellent paper in February 2008 - Comparing the Effectiveness of Therapies for Localized Prostate Cancer. The EXECUTIVE SUMMARY (which runs to 20 pages and is in pdf format) is well worth printing and studying. Some terms may be a little technical for the newly diagnosed, but can be understood with a little work and by asking questions.

A paper entitled QUALITY OF LIFE AND SATISFACTION WITH OUTCOME AMONG PROSTATE-CANCER SURVIVORS was also published in 2008. The link above will get you to a copy of the paper. It might also be worth reading the brief discussion on THE "NEW" PROSTATE CANCER INFOLINK which highlights two points:

"All that the data from this study can do is offer you some general guidance about what is reasonably expectable on average. The data are what they are. We wish better guidance could be offered, but it just isn’t available."

and

"The major takeaway from this study is that all forms of the most common types of treatment have some downsides. The degree to which these may affect the individual patient is the great unknown."

DEVELOPING A STRATEGY

Although we recommend doing your own research into the choice you think will suit you best, there are pitfalls. Although Steve Dunn was not diagnosed with prostate cancer he has some excellent general advice in "CANCERGUIDE: RESEARCHING YOUR OPTIONS". It may also help you understand some of the issues that give rise to the uncertainty in the "the practice of medicine" by reading INTERPRETING REPORTS, a contribution from Dr Wesley Root.

You will find many apparently contradictory statements as you do your research. Much of the confusion is due to the rivalry which exists between different branches of the medical profession. For this reason it is important to try to establish the background of anyone giving advice. In this way you may be able to detect potential bias. Broadly speaking, urologists tend to recommend surgery, because most of them are surgeons, while radiologists tend to recommend radiation therapy for the same diagnosis. A paper published in 2010 titled IS THERE AN OPTIMAL MANAGEMENT FOR LOCALIZED PROSTATE CANCER? (303KB pdf file) sets out the state of play fairly well, although it does not mention HIFU because that had not yet been approved by the FDA for use in the USA.

Donna Pogliano has some ADVICE TO THE NEWLY DIAGNOSED. This piece of advice was written in 2004. There have been some changes since then, notably the growth of RALP (Robotic Assisted Laparoscopic Prostatectomy) aka Da Vinci procedures and a greater focus on Active Surveillance. The basic advice is still relevant and sound. The piece is well worth printing to keep and review as you develop your strategy. Donna was a prominent prostate cancer activist and co-author of A PRIMER ON PROSTATE CANCER, THE EMPOWERED PATIENT'S GUIDE.

Another useful document showing a decision path is on the National Comprehensive Cancer Network® (NCCN) site. You can download a copy of the NCCN GUIDELINES FOR PATIENTS - PROSTATE CANCER which is supplied free of charge to registered users. (Registration is simple and there is no charge).

An article entitled "Comparative Analysis of PSA Free Survival Outcomes", by Dr. Peter Grimm et.al., was published in the British Journal of Urology International in 2012. The original article provided a comprehensive comparison of eleven different treatment methods, but it was written for medical professionals, so it was very difficult for most people to understand. Fortunately, the results were incorporated into a WEBSITE that presents the data in a graphical format that is relatively easy to understand. Many educated layman will be able to understand the results with just a little help with the statistics. (Many thanks to YANA member and retired physician Dr. Brooke Jennings for finding this valuable resource.)

MAKING YOUR CHOICE

The process of making a choice is a reiterative one. People will try to gain a good initial understanding of all the options and their potential consequences before rejecting some. They will then review the ones they have selected as potentially being the best for them, both as far as their diagnosis and their personal outlook on life. Through this process they should finally arrive at a decision that suits them best.

As part of the process, it might be worthwhile to use the MCHUGH DECISION SHEET and the MCHUGH CHEAT SHEET to focus on what you want and what is best for you. Dr John McHugh, the author of these documents is a urologist who was diagnosed in 2007.

If you feel you need to know more there are two sources of information that you might find helpful.

SURVIVOR STORIES on this site. More than one thousand men have contributed their experiences after diagnosis with prostate cancer. Most of the men will respond to any specific questions you might have. You can search the stories by a number of criteria to find a diagnosis similar to yours. Telling your story on the site, even if you are still undecided as to which choice you will make, will usually generate e-mail from some of the veterans. If you want to do that come and JOIN US.

The YANA FORUM or one of the MAILING LISTS. If you post there, setting out clearly the brief details of your diagnosis, the treatment option you are interested in and what additional information you need, you will almost certainly get a good response.

Both these sources of information are regarded with concern by some. It is felt that using anecdotal information from non-medical people can lead to poor decisions. However most people seem to understand the nature of the advice they get and where it is coming from and find it useful as a platform to discuss with their medical advisors.

OPTIONS

The most common options are listed below in alphabetical order from A through Z. Simply click on the one you wish to learn about and you will be linked to the appropriate place on the site. You may find that some treatments are known by more than one name, so some links will take you to the same place.

The basic information for each of the options usually includes links to other sites for more specific information. We have selected some that we think provide well presented information. All websites listed within the YANA website are for information purposes only - we do not endorse any particular website or organization. The choice is with you as an individual, taking into account your specific requirements.

  • ABIRATERONE
  • ACTIVE SURVEILLANCE
  • ALTERNATIVE THERAPIES
  • ANDROGEN BLOCKADE THERAPY
  • ANDROGEN DEPRIVATION THERAPY
  • BRACHYTHERAPY
  • CHEMOTHERAPY
  • COMBINED HORMONE THERAPY
  • CALYPSO RADIATION THERAPY
  • CAM - COMPLEMENTARY AND ALTERNATIVE MEDICINE
  • CASTRATION
  • CONSERVATIVE MANAGEMENT
  • 3D CONFORMAL RADIATION THERAPY
  • CRYOTHERAPY
  • CYBERKNIFE® RADIATION THERAPY
  • DA VINCI SURGERY
  • DART® RADIATION THERAPY
  • EXTERNAL BEAM RADIATION THERAPY (EBRT)
  • FOCAL THERAPIES
  • HIGH DOSE RATE BRACHYTHERAPY
  • HIGH INTENSITY FOCUSED ULTRASOUND (HIFU)
  • HORMONE THERAPY
  • HYPERTHERAPY
  • INTENSITY MODULATED RADIATION THERAPY (IMRT/IGRT)
  • IRREVERSIBLE ELECTROPORATION (IRE)
  • LAPAROSCOPIC PROSTATECTOMY (MANUAL)
  • LASER FOCAL THERAPY
  • NATURAL THERAPIES
  • NANOKNIFE (IRE)
  • OPEN SURGERY
  • ORCHIECTOMY/ORCHIDECTOMY
  • PC-SPES
  • PHOTODYNAMIC THERAPY (PDT)
  • PROVENGE
  • PROSTASOL
  • PROSTRCISION® RADIATION THERAPY
  • PROTON BEAM RADIATION
  • RADIATION - BRACHYTHERAPY
  • RADIATION - EXTERNAL BEAM (EBRT)
  • RADICAL PROSTATECTOMY
  • ROBOTIC ASSISTED LAPAROSCOPIC PROSTATECTOMY (RALP)
  • SALVAGE RADIATION THERAPY (SRT)
  • SALVESTROLS
  • SEED IMPLANTS
  • SURGERY - (RETROPUBIC PROSTATECTOMY AND PERINEAL PROSTATECTOMY)
  • SURGERY - LAPAROSCOPIC ROBOTIC RADICAL PROSTATECTOMY
  • TAXOTERE
  • WATCHFUL WAITING
  • ZYTIGA
  • ACTIVE SURVEILLANCE : WATCHFUL WAITING

    CONSERVATIVE MANAGEMENT

    The tag of Conservative Management is rarely used now. Both Active Surveillance (AS) and Watchful Waiting (WW) are used to describe the choice made by men who elect not to have immediate conventional treatment. A distinction is often made between the two:

    Active Surveillance (AS) involves undertaking a number of measures to track any changes in a diagnosed early stage, low risk or very low risk disease. In the event that there are significant changes, conventional treatment is undertaken with the intention of effecting a cure.

    Watchful Waiting (WW) involves tracking changes and looking to manage any progress of the disease without having initial invasive therapy.

    The premise of both WW and AS is that most prostate cancers diagnosed today are slow growing. If the cancer is early stage and low or very low risk there is a good probability that the man in whom it is detected may die of another cause. Undertaking conventional treatment with all the attendant negative consequences may be unnecessary in such cases. Data from the PIVOT STUDY published in July 2012 highlights this. There are two good commentaries on the THE "NEW" PROSTATE CANCER INFOLINK, the SECOND OF WHICH concludes:

    • For men with low-risk, early stage, localized prostate cancer who are older than 65 years of age and have a life expectancy of not more than 15 years, observation (i.e., active monitoring) is now shown to be every bit as effective as (and a great deal safer than) radical prostatectomy.
    • For men with low-risk, early stage, localized prostate cancer who are less than 65 years of age and have a life expectancy of more than 15 years, it is arguable that observation (i.e., active monitoring) may be at least as good an option as radical prostatectomy.

    Neither AS nor WW is regarded as a form of treatment in the sense that other therapies set out to 'cure' the cancer. However, it may be a good option for some men who have an appropriate diagnosis. Men most likely to have a suitable diagnosis for this option are those who have what the Brady Institute at Johns Hopkins Memorial Hospital has categorized as an "insignificant tumor", which they define as set out below. There are other definitions of what is termed "low risk cancer" which are similar:

    1. Nonpalpable - negative DRE (Digital Rectal Examination)
    2. Stage T1c or T2a
    3. Percent free PSA 15 or greater
    4. Gleason 7a (3+4) or less
    5. Less than three needle cores of twelve with none greater than 50% tumor

    To provide health care providers, public health practitioners, policymakers, and the general public with a comprehensive assessment of the current role of active surveillance in the management of men with localized prostate cancer, the National Cancer Institute, the Centers for Disease Control and Prevention, and the Office of Medical Applications of Research convened a State-of-the-Science Conference on December 5–7, 2011, to assess the available scientific evidence. Their report ROLE OF ACTIVE SURVEILLANCE IN THE MANAGEMENT OF MEN WITH LOCALIZED PROSTATE CANCER was published in January 2012 and concluded:

    Active surveillance has emerged as a viable option that should be offered to patients with low-risk prostate cancer. More than 100,000 men a year diagnosed with prostate cancer in the United States are candidates for this approach.

    If you are considering this option it may be of interest to read these:

    WATCHFUL WAITING AND ACTIVE SURVEILLANCE: THE CURRENT POSITION, published in July 2008

    ACTIVE SURVEILLANCE FOR FAVORABLE RISK PROSTATE CANCER: What Are The Results, and How Safe Is It? A paper published in October 2010

    ACTIVE SURVEILLANCE FOR PROSTATE CANCER: PATIENT SELECTION AND MANAGEMENT is of interest, with one of the main points concerning the surveillance patients, who were eventually treated. At a median follow up of about 8 years, absolutely no difference was observed in the mortality or the metastasis rate. Most of the men in the studies are still on AS. There is a post on the paper on the YANA FORUM.

    As long ago as 1997 a lawyer who posted as Lorenzo Q Squarf wrote a series of amusing (depending on your sense of humor) posts to a website and became involved in discussion on the Internet about why Watchful Waiting was the best option for most men. His website is no more - he went on his way, finding discussion of PCa 'boring' - and was last heard of in 2011 at the ripe old age of 79 when, after he published a book about his flying experiences, he provided a brief update. To get a taste - and some intelligent thinking - on the subject of Watchful Waiting, part of his website has been saved. It is here - FLAMEKEEPER OF WESTERN CIVILIZATION.

    The question 'to treat or not to treat?' has been raised by many experts in the field, including Dr Jonathan Oppenheimer, a leading pathologist in the US, who said this in 2008:

    "For the vast majority of men with a recent diagnosis of prostate cancer the most important question is not what treatment is needed, but whether any treatment at all is required. Active surveillance is the logical choice for most men (and the families that love them) to make."

    Positive consequences of active surveillance:

    • The potential serious consequences of the conventional treatment choices are avoided.
    • There is a possibility of spontaneous regression. It is difficult to even begin to estimate the probability of this occurring. However it is worth noting that between 25% and 33% of men in AS studies do not have a second or subsequent positive biopsy. This may be because of the "hit and miss" nature of biopsy procedures. There is a discussion on SPONTANEOUS REGRESSION on the Yana Forum which may be of interest. Dr Charles "Snuffy" Myers discusses this issue on his site at DOES CANCER EVER DISAPPEAR?.

    Negative consequences of active surveillance:

    • The monitoring process chosen might not identify disease progression early enough and late intervention may be less effective than early intervention.
    • There is a possibility of the initial diagnosis being incorrect because the diagnostic tools used at present are not very accurate
    • .
    • Most protocol for AS require repeat biopsy procedures which carry a small degree of risk.
    • Some of the problems associated with aging, such as an increase in BPH (Benign Prostate Hyperplasia), may create urinary bothers such as increasing frequency, nocturia and the like.

    BACK TO INDEX

    ANDROGEN DEPRIVATION THERAPY(ADT)

    HORMONE THERAPY : ANDROGEN BLOCKADE THERAPY

    This therapy has many acronyms and names. Some examples are ADT, ADT2, ADT3, CAB, CHB, CHB2, CHB3, CHT, HT, HBT. Technically all refer to the main object - to control the body's production or absorption of testosterone (T) or, more precisely, dihydrotestosterone, commonly referred to as DHT. Hormone therapy is sometimes described as a chemical ORCHIDECTOMY - the advantage is that it is reversible where surgical orchidectomy is not. A combination of drugs may be used to prevent production of testosterone by the testicles and to block the cancer tumor from using the testosterone produced by the adrenals. This can reduce the size of the tumor in about 80% of cases.

    Historically, hormone therapy was used mostly as a primary treatment of metastasized cancers or as a salvage procedure for a failed treatment. The main measure of effectiveness is the reduction in PSA levels. In some cases this is confirmed by the retreat of metastasized lesions. It is also used as a primary treatment to reduce the size of the prostate prior to other treatment - referred to as neo-adjuvant therapy - and sometimes after primary treatment, such as radiation therapy, when it is referred to as adjuvant therapy. Some surgeons will not operate on a prostate where this therapy has been used prior to surgery as the treatment alters the cellular structure of the gland itself.

    As is the case with most issues to do with prostate cancer, there is considerable disagreement about when and how this therapy should be applied. One area of considerable disagreement has been the concept of interrupting the therapy when it appears to have achieved a preliminary aim - the reduction in PSA levels. The therapy is then resumed if and when PSA levels rise again. Some studies indicate that such action may not be less effective than continuous therapy whilst producing less negative consequences.

    An excellent document has been produced recently (April 2012). It is entitled HORMONE THERAPY FOR PROSTATE CANCER - A PATIENT GUIDE and it is well worth reading.

    The drugs used often have different names in different countries which can cause a deal of confusion for the man trying to find information. It can be very useful to use a search engine like Google to track these names. Some of the common names of the drugs used to suppress the production of T (Testosterone) are: Lupron (leuprolide acetate) and Trelstar (triptorelin pamoate) which are both injected intramuscularly into the buttock. Zoladex (goserelin acetate) and Firmagon (degarelix acetate) both injected subcutaneously into the lower abdomen. Viadur (leuprolide acetate) which is surgically implanted into the upper arm.

    Although leuprolide acetate is marketed as Viadur, Eligard, and Lupron in the USA, Lucrin is the name used in countries like New Zealand, Australia, Belgium, Costa Rica, Malaysia, Singapore and South Africa. In the UK and Ireland, leuprorelin is marketed as Prostap SR (one-month injection) and Prostap 3 (three-month injection).

    Positive consequences of ADT:

    • When used as a primary treatment of metastasized cancers or as a salvage procedure for a failed treatment, the disease can be managed, sometimes for many years. The popular delusion that this therapy will always fail within a year or two is simply not correct.
    • When used as a neo-adjuvant or adjuvant therapy, there is some evidence that the outcome of the primary therapy may be improved.
    • There is a growing body of evidence indicating that if this therapy is 'pulsed' or administered on an intermittent basis, the negative consequences may be less severe without affecting the ultimate outcome.

    Negative consequences of ADT:

    • Reported negative consequences of this therapy are numerous and are sometimes referred to as ANDROGEN DEPRIVATION SYNDROME, which results from lack of testosterone. Some, but not all may be reversible if the treatment is stopped. Some of the frequently identified negative consequences are listed below:
    • The principle negative consequence of major concern to men are loss of libido - the desire for sexual activity - and erectile function - the ability to have an erection. This therapy is often referred to as "chemical castration" and men can be as eunuchs because of this. Although little can be done about the effects of loss of libido and erectile function, whilst the drug is being administered this piece - CASTRATED, EMASCULATED, BUT HARDLY DISEMPOWERED! - might be useful for men concerned about emotional aspects of these issues. There are links to useful sites dealing with erectile dysfunction in the SURGERY section.
    • Because there is a change in hormonal balance, emotions can change significantly, with some men reporting depression and other emotional changes. Lack of clarity of thinking and memory issues are also reported. A small pilot study published in September 2012 titled "Cognitive problems in patients on androgen deprivation therapy" is analyzed on THE "NEW" PROSTATE CANCER INFOLINK.
    • One of the most serious negative consequences, especially where there is long term use, is loss of bone mineral density or osteoporosis, which can result in fractures and/or collapse of spinal vertebrae. This potential problem often gets less attention than it should because it is less obvious until it may be too late.
    • Less serious, but very annoying is the development of what are termed in the USA as hot flashes and as hot flushes in other version of English. There are no direct health risks but these consequences may be relieved by using, with the approval of your medical advisor, DEPO PROVERA (medroxyprogesterone, a synthetic form of the female hormone progesterone) or PAXIL (paroxetine hydrochloride) or EFFEXOR (venlafaxine hydrochloride).
    • Other general negative consequence are weight gain, fatigue or loss of energy, loss of muscle mass, development of small breasts - medically termed GYNECOMASTIA, loss of body hair and a general 'feminising' of the body. Although gynecomastia is not uncommon in men who are not on this therapy, some men contemplating using ADT will have a light radiation of the breast which, it is claimed, will reduce the probability of this condition developing. As to muscle loss and fatigue, many men have anecdotally reported that by increasing their exercise levels they have been able to maintain their weight and energy levels and muscle mass.
    • Many men using ADT to manage their disease will develop what is termed CRPC (Castration-Resistant Prostate Cancer) which is also known by many other terms, the most common being AIPC (Androgen Independent Prostate Cancer) or HRD (Hormone Resistant Disease). When this happens ADT is no longer effective and the man will need to consider moving on to another therapy. This has in the past meant CHEMOTHERAPY, but there are other promising therapies being developed, the most well known at present being PROVENGE. The AUA American Urological Association released revised guidelines to the management of men with CRPC in May 2013. You can read them here CASTRATION-RESISTANT PROSTATE CANCER: AUA GUIDELINE

    A source of very detailed information on this subject is A Primer on Prostate Cancer: The Empowered Patients Guide by Donnna Pogliano, a prostate cancer activist. She co-authored the book with Dr Strum. It is not an 'easy read' to glance through while lounging by the pool, but it allows laypeople to get a good understanding of complex medical issues. The ISBN number is 0-9658777-6-0 and it has been available at Amazon and Barnes & Noble as well as at the LIFE EXTENSION FOUNDATION site, whose support saw the book published.

    Long term prostate cancer survivor CHUCK MAACK (he was diagnosed in 1992 and has used ADT for many years to manage his disease) has collected information which he terms Observations, including some detailed aspects of ADT on his own website THE PROSTATE ADVOCATE.

    BACK TO INDEX

    CASTRATION: ORCHIDECTOMY/ORCHIECTOMY

    The orchidectomy or orchiectomy procedure is a surgical procedure where the testicles are removed. This is done because it is an effective method of lowering the man's testosterone level. Indeed it was the only way to create this effect before the development of the drugs used more widely now. It is important to reduce the level of testosterone as, in the current view, this is a major source of 'fuel' for the growing prostate cancer. Although this procedure is still done, it is usually only in countries where the cost of medication is unaffordably high. It may also be suggested by some urologists if a man is diagnosed with advanced prostate cancer late in his life. There is some technical information on the procedure at WHAT IS ORCHIECTOMY?

    A similar effect can be produced through the use of ANDROGEN DEPRIVATION THERAPY (ADT), which is reversible; an orchidectomy is not.

    Positive consequences of orchidectomy: The reduction of testosterone will usually lead to a lowering of the PSA numbers and some alleviation of the symptoms which men with advanced prostate cancer have.

    Negative consequences of orchidectomy: The main potentially negative consequences are similar to those for ANDROGEN DEPRIVATION THERAPY (ADT) so are not repeated here. In addition there are often psychological issues. Prosthetic implants inserted in the scrotum can help in this regard.

    Ric Masten was a poet. He had an orchidectomy. For his view of his procedure, read his poem BILATERAL ORCHIDECTOMY

    BACK TO INDEX

    CHEMOTHERAPY

    It would be very unusual for chemotherapy to be used as a primary therapy for early stage prostate cancer, the most commonly diagnosed form of the disease. It's main use is in connection with late stage disease, either on diagnosis - a small number of cases these days - or where the primary therapies have failed and where hormone refractory cancer has developed. This is commonly termed HRPC or androgen independent prostate cancer (AIPC), although there are other terms. This hormone refractory stage is where ANDROGEN DEPRIVATION THERAPY (ADT) is no longer effective. In most cases where chemotherapy is used there will be evidence of metastasized disease.

    Historically studies showed that chemotherapy was not a very effective treatment for prostate cancer and there were very serious negative consequences from the large doses of toxic chemicals used. In recent years, use of chemotherapy for prostate cancer has changed significantly and smaller, intermittent doses are now used. This has resulted in less negative consequences and seems to provide a better tool to manage the disease. There are no claims that chemotherapy can 'cure' prostate cancer, but there is a growing body of evidence that shows that the disease can be managed for some time using modern drugs.

    There is an excellent summary of the 'state of play' at June 2010 in this piece THE CONVERSATION BEHIND THE SCENES AT ASCO on The "New" Prostate Cancer Infolink. Some of the therapies mentioned in this piece have subsequently been approved and are in general use. A very useful site that offers the general information on chemotherapy for cancer patients and their families, caregivers and friends is Scott Hamilton's site CARE DURING CHEMOTHERAPY AND BEYOND A useful paper, mainly aimed at people diagnosed with esophageal cancer, but providing good insight into nutrition during chemotherapy is THE FULL SPECTRUM

    Positive consequences of chemotherapy:

    • Many of the studies show what might be considered relatively short extension of life expectancy. For example the difference in survival in the well publicized PROVENGE study was only four months. However this is in the comparison of median survival periods and, as this piece THE MEDIAN ISN'T THE MESSAGE demonstrates so clearly, it is the range of survival times that is more important than the median. One well known oncologist claims that modern chemotherapy means that the majority of men treated will live out their normal life span. In considering this statement it should be borne in mind that many men treated with chemotherapy are old or sickly and may not have a long normal life span.

    Negative consequences of chemotherapy:

    • There is a wide spectrum of negative consequences although these are less severe than those encountered historically. They may still impact severely on men who are not well when they start the therapy. The loss of hair is less common than it was and even the intense nausea that was inevitable is less so. One such drug, Taxotere, has had multiple reports of ADVERSE SIDE EFFECTS.

    BACK TO INDEX

    COMPLEMENTARY AND ALTERNATIVE MEDICINE THERAPIES (CAM)

    There are many definitions of Alternative Medicine. Probably the most widely used - in the USA in any event - is 'medical interventions not taught at United States medical schools or not available at United States hospitals.' A more international definition might be 'an unrelated group of non-orthodox therapeutic practices, often with explanatory systems that do not follow conventional biomedical explanations.'

    These practices are often referred to as 'quackery', yet indications are that an ever-increasing number of people in the USA and Europe are resorting to them. Sometimes they are used alone as an alternative to conventional treatment; sometimes they are used as a complement, to help conventional treatment.

    There are many claims made for alternative medicine that do not stand up to scrutiny and so it is important to be aware of this before accepting professed claims from people who are making money from their claims. There are three basic questions that should be answered - and they may also apply to conventional medicine.

    1. Is there any independent evidence to support the claims being made?
    2. Will the person providing the information benefit directly or indirectly from what they are claiming?
    3. How long is it since the evidence supporting the claim was collected or completed?

    An example of this approach is in the JANUARY 2012 YANA-E LETTER under the header Will this work?

    Steve Dunn gives a good preliminary view on the value of Alternative Medicine on his site at STEVE DUNN'S CANCERGUIDE MATERIAL ON ALTERNATIVE THERAPIES. If you do go there, be sure to also read the two sections of the site - ALTERNATIVE THERAPIES: HOPE OR HYPE? and SEPARATING THE WHEAT FROM THE CHAFF

    For a widely-praised example of what the medical profession thinks we should all be aware of - go to QUACKWATCH. Check the index for any specific treatment or therapy, but be aware that some of the entries may not meet the three criteria set out above.

    The ANNIE APPLESEED PROJECT provides information, education, advocacy, and awareness for people with cancer and their family and friends. There is a very broad range of information which will be helpful in evaluating alternative options. The MEMORIAL SLOAN-KETTERING CANCER CENTER (MSKCC) web site has a database on use of hundreds of vitamins, herbal agents, botanicals, and supplements. This database has been developed by the Department of Integrative Medicine at MSKCC.

    Smilow Comprehensive Prostate Cancer Center claims that they have a specialty focussing on HOLISTIC TREATMENT OF PROSTATE CANCER. The principles of their approach show nothing that is really new. However they are one of a small number of institutions providing an integrated series of therapies.

    There is also an excellent book dealing with the subject: CHOICES IN HEALING by Michael Lerner. (This book can be read online free of charge - it is highly recommended reading, with a suggestion that reading the last chapter first, may provide some comfort and insight).

    Nelson Berman has written an account of his decision to take the Alternative route - his site is at CANCER IS NOT THE ENEMY.

    PC-SPES AND PROSTASOL are probably the best known alternative therapies. PC-Spes is no longer available but there are many compounds making similar claims for efficacy. The best known is Prostasol.

    SALVESTROLS It seems that there may be a focus developing on this compound, developed by Dr Gerry Potter, credited with the original research which led to the development of ZYTIGA.

    Positive consequences of CAM:

    • Some complementary and alternative medicine therapies may well improve overall health. This may then enhance the immune system to such an extent that the cancer is sent into regression.
    • The consequences of conventional therapies may be lessened or managed better by using complementary and alternative medicine therapies.

    Negative consequences of CAM:

    • Some complementary and alternative medicine therapies may clash with conventional medication. For this reason, the use of such therapies should always be discussed with medical advisors before commencing the therapy.
    • Very few complementary and alternative medicine therapies have clear evidence for their efficacy in managing prostate cancer. Relying on such therapies can result in the disease advancing to a stage where any prospect of cure by conventional means is lost.

    BACK TO INDEX

    CRYOTHERAPY

    In recent years there has been renewed interest in using cryotherapy for localized prostate cancer. This therapy destroys prostate tissue (both cancerous and normal cells) by freezing the prostate gland with liquid argon which is delivered through thin needle-like probes.

    The probes are placed through the perineal skin - between the scrotum and anus. They are guided using transrectal ultrasound which is also used to monitor the freezing process in real time. The number of probes will vary depending on the size of the prostate and the position and size of any specific tumor sites. Liquid argon gas is used to reduce the temperature very rapidly.

    Although this treatment is referred to as being effective because of the freezing of the gland and thus destroying the tissue, it is, in fact, the very rapid thawing process which ruptures the cell membranes effectively killing the cells. The freezing/thawing cycles is usually carried out in two or three cycles. A catheter is inserted in the urethra, which carries urine from the bladder to the penis, and warm liquid is circulated during the procedure to stop the freezing of cells in the urethra to limit any urinary problems.

    When this procedure was first used, the entire gland was destroyed resulting in a high rate of erectile dysfunction (ED) - almost 100% of men were impotent according to some studies. Later refinements have seen a more targeted approach, which aims at destroying only identified tumors and the healthy cells in the immediate vicinity of the tumor. This can leave some or all of the erectile nerves untouched and results in levels of ED that are comparable with those resulting from other treatments. This is usually referred to as FOCAL THERAPY.

    One advantage this form of treatment is that it can be repeated. It can also be used as a salvage procedure for other failed treatments, notably radiation treatment - EBRT (External Beam Radiation Treatment) or Brachytherapy.

    This CRYOTHERAPY site is a very useful one for anyone considering this option.

    One of our Mentors, the late COLIN CAMPBELL wrote a piece "WHY CRYOSURGERY" that may be of interest.

    Gary Onik is a pioneer of this therapy. FOCAL NERVE SPARING FOR CRYOTHERAPY (a downloadable pdf) was published in 2002 and describes a pilot study. A later paper published in 2005 is available at HEALTHY AGING or may be accessed as THE MALE LUMPECTOMY - a printable Word.doc

    Men considering this option might find it helpful to review STUFF TO TAKE WHEN EXPERIENCING CRYOSURGERY, written by a man who underwent this therapy and wanted to share his experience.

    Positive consequences of cryotherapy:

    • Although there are no good, long term studies to determine the efficacy of cryotherapy, published data indicates similar 'cure rates' to other therapies for low risk or very low risk diagnoses. It is unusual for cryotherapy to be used for high risk diagnoses. Effectiveness is measured by taking PSA tests. Typically it may take about three months for PSA numbers to reach their nadir - their lowest level.
    • Cryotherapy can be used as a salvage therapy in the event of failure of initial therapy.

    Negative consequences of cryotherapy:

    Short Term:

    • The entry of needles in the perineum can cause irritation, swelling and inflammation in this and the genital areas. This usually responds to icing and anti-inflammatory drugs.
    • Fluid can also collect in the scrotum, although this is more rare. Medical help should be sought.
    • There may be some itching and burning during urination in the immediate aftermath of the treatment as well as some urgency and blood in the urine. These consequences usually dissipate over a few days. If they do not, medical help should be sought.
    • Damage may occur to the urethra, despite the precautions taken to keep this area warm. This damage may lead to what is termed urethral sloughing - the passage of dead tissue through the urethra. In severe cases there will be urinary obstruction requiring medical treatment - usually catheterisation initially. Men who have undergone transurethral resection of the prostate (TURP) or using cryotherapy as a salvage treatment are at higher risk for urethral sloughing.

    Long Term:

    • Although the incidence of Erectile Dysfunction (ED) - the inability to have an erection - is reportedly similar to other therapies where a focal therapy is carried out, full cryotherapy usually results in loss of erectile function
    • The development of a fistula is one of the more serious consequences of cryotherapy. The numbers of fistula occurring has been reduced with modern technologies. In the worst cases, a channel forms between the urethra and the rectum. This allows matter - urine and fecal matter - to pass from one part of the body into another. The results can include diarrhea, rectal incontinence or urinary tract infections.
    • Most urinary problems that might arise are likely to be short term as listed above.

    BACK TO INDEX

    FOCAL THERAPIES

    One of the significant advances in the treatment of breast cancer was the development of the so called "lumpectomy". This procedure sees the removal of only the material identified as cancerous instead of the entire breast - the mastectomy, which was standard practice. The lumpectomy can only be done in suitable cases where the disease is diagnosed at an early stage. It is claimed that there is a similar success rate to mastectomy procedures in such cases.

    The question inevitably arose as to whether a similar process could be applied to early stage prostate cancer. To date there is no surgical procedure which will only remove a part of the prostate gland, but there are some therapies for which it is claimed that only the diseased part of the gland will be ablated (destroyed) by the treatment. The main therapies for which this claim is made to date are CRYOTHERAPY, HIGH INTENSITY FOCUSSED ULTRASOUND (HIFU), PHOTODYNAMIC THERAPY (PDT), IRREVERSIBLE ELECTROPORATION (IRE) and LASER FOCAL THERAPY. Some of these are at the time of writing (March 2013) regarded as experimental and some are known by other terms. Detailed information as to how they are applied and the potential consequences are detailed in the relevant sections dealing with these therapies where such information is available.

    One of the main issues when considering whether to have a focal therapy, with its promise of potentially reduced negative consequences, is how to identify just which part of the gland is to be treated and which is to be preserved. There are essentially two options neither of which is entirely satisfactory because of the heterogeneous nature of prostate cancer which commonly is multi-focussed. There is a very real possibility of some cancerous material being missed and therefore not treated.

    Scans used at present are far from accurate, producing both false positive and false negative results. That is to say they sometimes miss tumors and at other times signal that there are tumors where none exist. There is some evidence that the use of what are termed COLOR DOPPLER scans may increase the probability of tumors being identified.

    Biopsy: A more common approach in trying to identify the presence of tumors is to undertake what is usually termed as a saturation biopsy procedure. Other terms are also used for this procedure. Where a normal biopsy procedure will use twelve needles to take samples, the saturation biopsy will use upwards of thirty needles, the precise number depending on the estimate size of the prostate gland. This procedure is carried out under anesthesia and entry is through the perineum - the area between anus and scrotum. The multiple results are then plotted on a grid to identify any diseased areas.

    A good paper published by PCRI in 2010 REVIEW OF FOCAL THERAPY FOR LOCALIZED PROSTATE CANCER summarizes the position well.

    Positive consequences of focal therapies:

    • If the focal therapy is accurately guided to ablate only diseased tissue, there is a significant reduction in the potential for negative consequences.
    • If the focal therapy fails initially it can be repeated, aimed at any new area identified as being missed on the first treatment.
    • The limited number of studies on focal therapies show that they are most successful with low risk or very low risk diagnoses. There are no long term studies of focal therapies.

    Negative consequences of focal therapies:

    • Although an accurately guided focal therapy procedure will reduce the probability of negative consequences significantly, the consequences associated with the relevant 'non-focal' therapies are still possible.
    • In trying to minimze the negative consequences of the focal therapy, some small clusters of cells may be missed and not treated.

    BACK TO INDEX

     

    HIGH INTENSITY FOCUSED ULTRASOUND (HIFU)

    HIFU is a FOCAL THERAPY. Ultrasound waves are focused on targeted areas of the prostate which are heated to temperatures of 80 to 100 °C — very much higher than the normal body temperature of 37°C. This kills the tissue on which they are focused. In effect HIFU is the precise reverse of CRYOTHERAPY. One freezes the prostate cancer to death, the other cooks it to death.

    Much of the information about HIFU is supplied by the two major manufacturers ABLATHERM® and SONABLATE® 500 and should be viewed in that light. A paper published in 2005, TRANSRECTAL HIFU: THE NEXT GENERATION?, highlights some of the significant differences between the two manufacturers' equipment and operation.

    This procedure is still regarded in many circles as experimental for prostate cancer although it has been used for some years in Europe. One manufacturer claimed in 2009, ten years after development of their prototype machine, that more than 15,000 men had been treated with their equipment at about 180 centers around the world - mainly in Europe. At September 2010 HIFU had been approved for use in Australia, Bahamas, Bermuda, Britain, Canada, China, France, Germany, Japan, Korea, Mexico and Puerto Rica. In the United States, the Food & Drug Administration (FDA) approved the SONABLATE® 450 device for use in treating Prostate Cancer in October of 2015. Previously, many men in the US traveled to nearby countries for the procedure. The National Institute for Health and Clinical Excellence (NICE) has issued FULL GUIDANCE to the use of HIFU which may be of interest to anyone contemplating the use of this therapy. It was reported in March 2013 that documentation had been submitted to the U.S. Food & Drug Administration (FDA) for pre-market approval of the Ablatherm device - EDAP TMS SUBMITS DATA FOR APPROVAL OF HIFU TO US FDA.

    There are few independent published studies. These are commentaries on some of those published since 2009 with links to Abstracts of the original studies which are, of necessity, not based on US data:

    UK study 2009: CONTROVERSY IN THE APPROPRIATE USE OF HIFU

    French study 2010: HIFU IS NOT NECESSARILY AS SAFE AS SUGGESTED

    German study 2010: BLADDER OUTLET OBSTRUCTION: A COMMON SIDE EFFECT OF HIFU

    Korean study 2012 : HIFU "DOES NOT PROVIDE EFFECTIVE ONCOLOGIC OUTCOMES"

    Small initial short term UK trial 2012: FOCAL HIFU IN MEN WITH LOCALIZED PROSTATE CANCER

    Canadian men treated with HIFU 2012: 4-YEAR BIOCHEMICAL PROGRESSION-FREE SURVIVAL (bPFS)

    Regensburg in Germany HIFU data 2013: HIFU OUTCOMES IN GERMANY AFTER 8 YEARS OF FOLLOW-UP

    Specialists who can carry out the HIFU procedure in countries adjacent to the US are listed in HIFU - PHYSICIANS AND DOCTORS DIRECTORY. At March 2013, the site had not been updated for eighteen months. It seems that this site might replace a previous site which was the subject of this commentary: WHY YOU SHOULDN'T BELIEVE EVERYTHING YOU READ.

    Another form of heat treatment for prostate cancer has been termed "hypertherapy". This is the speciality of a German clinic and their claim is that by heating the prostate gland cancer cells are killed while healthy cells remain untouched. This appears to be a form of hyperthermia. Hyperthermia has been used for many years, usually in conjunction with other therapies such as EBRT (External Beam Radiation Therapy) or Chemotherapy. Some information is on the BICHER CANCER INSTITUTE site. Although claims are made that this procedure can be used successfully for prostate cancer, there are no specific studies that demonstrate this. The studies listed on the site appear to have Dr Bicher as the author.

    Positive consequences of HIFU:

    • There is no invasive surgery. The beam of ultrasound rays is delivered transrectally into the prostate, through the rectal wall closest to the prostate.
    • Ultrasound is not an ionizing form of radiation (which radiotherapy is). Therefore tissue along the entry path and the exit path of the ultrasound beam may be less likely to be significantly affected.
    • It is a single treatment, like seed implants - BRACHYTHERAPY. One day — in and out (at least in theory).
    • It is a repeatable treatment. In other words, if the first round of treatment fails to deal with the tumor it is possible to have a second treatment.

    Negative consequences of HIFU:

    • There is no doubt that there have been serious consequences associated with HIFU, the worst of which result in painful rectal fistula and bladder obstruction. It is claimed that these poor consequences are associated with early procedures or poorly trained operators.
    • It is possible that the long term 'cure rates' may not be as good as other therapies and that there may be long term negative consequences. There are no studies in this connection.

    BACK TO INDEX

    IRREVERSIBLE ELECTROPORATION (IRE)

    NANOKNIFE

    In recognition of the negative consequences of the most common treatments, there has been a number of efforts to develop what are termed FOCAL THERAPIES. One such development is termed Irreversible Electroporation (IRE) which is also known as Nanoknife It is far from clear why, apart from marketing implications of 'something new' the term 'nano' was introduced, since there is no nano technology apparent in the material published to date.

    It is claimed that IRE uses short pulses of direct electric current to create irreversible damage to cancer cell membrane thus causing cell death. It is also claimed that any other cells damaged in the process will regenerate, although it is far from clear why cancer cells will not also regenerate. The electrodes that provide the pulses of electric current are placed in pairs on each side of the target material. This creates the same problem for IRE as it does for other focal therapies - the inability to identify precisely all the material that is to be ablated. A paper authored by leading researcher Dr Gary Onik, IRREVERSIBLE ELECTROPORATION: IMPLICATIONS FOR PROSTATE ABLATION, sets out the procedure. Some of the detail seems to clash with that in the German site, translated as GENTLE TREATMENT OF PROSTATE CANCER.

    This proposed therapy is without a doubt classified as experimental.

    BACK TO INDEX

    LASER FOCAL THERAPY

    In recognition of the negative consequences of the most common treatments, there has been a number of efforts to develop what are termed FOCAL THERAPIES. One study for which a completed formal Phase I trial was completed in 2013 used MRI guided laser beams generated by a device inserted through the perineum into the prostate gland.

    The use of heat to attack the cancer cells is the same concept as that used in HIFU but the delivery system is very different. A small catheter is inserted and used it to guide a tiny optical fiber, the laser and a cooling device into the prostate. Under MRI guidance, the laser is positioned within the cancer and used to heat the area to a temperature that would kill cancer cells. Temperatures outside the treatment region are checked to protect healthy tissue, especially those near critical structures such as the urethra and rectal wall.

    The Media Release regarding the initial study is titled FOCAL THERAPY OFFERS MIDDLE GROUND FOR SOME PROSTATE CANCER PATIENTS and there is a good commentary on the paper at DATA FROM A FORMAL PHASE I TRIAL OF MR-GUIDED, FOCAL LASER SURGERY

    This proposed therapy is without a doubt classified as experimental.

    BACK TO INDEX

    PC-SPES : PROSTASOL

    PC-Spes (Spes is the Latin word for Hope) was regarded as an alternative treatment that worked and there were many reports of excellent results. At least one study was being undertaken and the early report were promising that this might be, as was claimed, a herbal recipe that could cure prostate cancer, at least as demonstrated by the control of PSA results.

    Concerns were raised however that the compound might rely on estrogen compounds and that these might give rise to thrombosis. The compound did not have FDA approval and was heavily criticized in The New England Journal of Medicine -- September 17, 1998 issue. It was withdrawn from the market following action by the government of California and was the subject of considerable litigation. There are other clones such as PC-HOPE, PC-CARE and PC-PLUS which are claimed to be as effective as PC-Spes, although none appear to be so, based on anecdotal evidence. The article linked above concludes with this stern warning:

    "Using these herbal products instead of conventional treatments for prostate cancer could be very harmful to your health."

    One of the best known clones is a compound marketed as PROSTASOL. There are said to be two versions of this - Dr Donsbach's which is apparently made in Mexico and marketed mainly in the USA and another marketed in Europe. The precise compound of Prostasol is unknown, the contents are not stated on the packaging and may change from time to time. It also appears that there may be significant differences between the Mexican and European versions. The DANISH MEDICINE AGENCY WARNING published in 2007 states in part: "The description of the contents states that Prostasol is a pure herbal product, but a Danish analysis shows that Prostasol contains diethylstilbestrol (synthetic estrogen)." There have been reports of men suffering from thrombosis - see PROSTASOL AND VENOUS THROMBOEMBOLISM as an example - and great care should be taken in using these compounds, which should only be taken under medical supervision. It may be necessary to use warfarin/coumadin to reduce the potential for blood clotting.

    DR DONSBACH was arrested in April 2009, and charged with 11 felony counts including treating patients without a license, misbranding drugs for sale, grand theft, unlawfully dispensing drugs as a cure for cancer, and falsely representing a cure for cancer. When the case came to trial in 2010 Donsbach pleaded guilty to thirteen felonies: five counts of practicing medicine without a license, five counts of selling/distributing misbranded drugs, and one count each of attempted grand theft, grand theft, and being a felon in possession of a firearm.

    The reference to a previous felony was to a crime for which Donsbach was sentenced to a year in jail, although he did not serve this time. He also admitted that he personally inflicted a great bodily injury on one of the victims related to the unlicensed practice of medicine. The Court agreed to sentence Donsbach to probation, which will include restrictions against practicing medicine and distributing dietary supplements, and possible custody in the county jail.

    BACK TO INDEX

    PHOTO DYNAMIC THERAPY (PDT)

    PHOTODYNAMIC THERAPY(PDT) has been used to treat cancer for more than 25 years. Although the focus has been primarily on surface or superficial lesions, such as skin cancer, there has been a movement to find ways of treating deeper malignancies, such as prostate cancer. The way in which this therapy works is that a photosensitizing drug is introduced. When this is irradiated by light at a specific wavelength it generates cell death, primarily through apoptosis, micro vascular damage, and an anti-tumor immune response. In treating prostate cancer infrared light is introduced to the gland by probes inserted through the perineum in much the same way as Brachytherapy probes.

    The procedure has not been approved by the FDA for the treatment of prostate cancer. There is a growing body of evidence concerning its efficacy and the innate minimally invasive characteristics of PDT suggest that it should become an important addition to the growing array of techniques in interventional oncology, provided that the issues raised in FOCAL THERAPIES are resolved.

    An excellent piece published in Nature Clinical Practice Urology in early 2009 is PHOTODYNAMIC THERAPY FOR PROSTATE CANCER-A REVIEW OF CURRENT STATUS AND FUTURE PROMISE. It is a fairly technical article but this paragraph extracted from the article sums up the conclusions :

    The benefits of prostate cancer treatment depend upon eradication of cancer within the gland, while the harms of treatment are related to unwanted effects outside the gland. When treatment is limited to either the prostate gland itself, or the areas of cancer within the gland where possible, then there is the potential to achieve the survival benefits of radical treatments in those men who require it, while avoiding the associated adverse effects. Such an approach would have to eradicate clinically relevant cancer, while at the same time leave the structures that surround the prostate (including the rhabdosphincter, rectum, neurovascular bundles and ejaculatory apparatus) intact. Eventually, a systemic but targeted therapy will likely meet these requirements; however, as no obvious compound with these attributes is currently in clinical studies, it is fair to assume that we are at least a decade away from such a treatment becoming a reality.

    BACK TO INDEX

    PROVENGE - SIPULEUCEL-T

    Provenge - Sipuleucel-T (APC8015) - is manufactured by Dendreon Corporation, and is referred to as a therapeutic cancer vaccine for prostate cancer. This is an unusual term for those who think of a vaccine in terms of a preventive vaccine, which prevents infectious disease. Provenge does not do that. In practical terms Provenge operates as an immunostimulant. The therapy is a complex one to administer and has to be prepared specifically for each patient. Because of this it is expensive, being marketed initially at a cost of $93,000.

    The first step is a process known as leukapheresis which separates out white blood cells - primarily dendritic cells - which are required for the therapy and and which then returns the remaining blood to the circulation. This process takes about three hours during which the man has to remain still and in a supine position.

    The cells that have been removed from the blood are then processed by Dendreon . The process prepares the dendritic cells for targeting the antigen prostatic acid phosphatase (PAP) which is said to be present in 95% of PCA cells and boosts their immune signaling factors.

    The activated blood product is returned to the infusion center and re-infused into the patient with the aim of causing an immune response against cancer cells carrying the PAP antigen.

    A complete Provenge treatment requires three collection/reinfusion procedures over the span of a month, with two weeks between successive procedures.

    There has been a great deal of controversy regarding Dendreon and the development for Provenge for many years. There have been allegations of conflicts of interest among two members of an FDA advisory panel, stock price manipulation and patent protests over delays in approval. The controversy continues still with sales of Provenge much lower than projections leading to staffing reductions and changes in management.

    The IMPACT trial that served as the basis for licensing approval of Sipuleucel-T by the FDA enrolled patients with metastatic androgen independent prostate cancer (AIPC) also known as hormone resistant prostate cancer (HRPC) It was claimed that the median survival time for Sipuleucel-T patients was 25.8 months comparing to 21.7 months for placebo-treated patients- a statistical significant period of four months.

    Some doubts have been cast regarding the data presented by Dendreon. Two articles in this connection are NEW DOUBTS ABOUT PROSTATE-CANCER VACCINE PROVENGE (March 2012) and THE PROVENGE VACCINE & A DISCREPANCY OVER DATA (November 2012).

    Positive consequences of Provenge:

    • Dendreon point to four months increase in survival in men treated with Sipuleucel-T over men in the IMPACT study. The survival times of 25.8 and 21.7 months respectively are the median survival periods. In other words half the men in each arm of the study died within the median periods while the other half did not die within that period.

    Negative consequences of Provenge:

    • Most negative consequences reported were limited to chills, fever, fatigue, nausea and headache occurring within the first few days of each round of treatment.
    • Men in the Sipuleucel-T arm of the IMPACT study had 50% more serious cardiovascular events than those in the placebo arm.

    BACK TO INDEX

    RADIATION - BRACHYTHERAPY

    SEED IMPLANTS and HIGH DOSAGE RADIATION

    Radiation therapy is most commonly by way of EXTERNAL BEAM RADIATION THERAPY (EBRT). This means that the radiation is generated outside the body and focused on the tumor. One of the concerns about EBRT (external beam radiation therapy) is that there is a potential for damage to other parts of the body through which the beam must pass. Brachytherapy on the other hand involves the insertion of radioactive seeds into the gland adjacent to the tumor with the aim of limiting consequential damage to other organs. There are some concerns in brachytherapy relating to the precise placement of the radioactive seeds and the potential movement of the seeds. Some practitioners use what is termed 'stranding' where the seeds to be implanted are placed in a degradable sheath. Others implant seeds individually. The seeds are each about the size of a grain of rice. They are either left in the gland permanently (this is commonly known as SI - seed implants) or seeds with a higher radiation dosage are inserted for a limited time and then removed (this is known as HDR - high dosage radiation).

    Brachytherapy is usually considered as an alternative to surgery for men with a suitable diagnosis - usually men with a PSA below 10 with no palpable disease, and who have a Gleason Grade no greater than 6 or 7a. Brachytherapy is not a good option for a man who has previously had a TURP (Transurethral Resection of the Prostate), who has a very large or very small prostate gland or who has a history of urinary tract infections (UTI).

    Both SI and HDR procedures approach the gland through the perineum - the area between the anus and the genitals. An array of 15-20 thin plastic needles are used to deliver the seeds into the designated position. In the SI procedure the seeds are left in place; in the HDR procedure the seeds are withdrawn after a few minutes, having delivered the measured dose. SI is a relatively short procedure, taking two or three hours; HDR usually requires four treatments, lasting a few minutes each, given over two days. The man can go home and carry on with his normal activities immediately after SI; HDR might need an overnight stay in hospital. There is sometimes a feeling of fatigue, as is the case with EBRT, but this usually recedes with time, as the dosage from the seeds reduces (they are only fully active for about six months).

    There are many variations to the basic procedures. As mentioned in ANDROGEN DEPRIVATION THERAPY (ADT), medication might be prescribed before brachytherapy (often to reduce the size of the gland and possibly make the cancer cells more susceptible to radiation damage). This is known as neo-adjuvant therapy. The medication may also be taken after the procedure, the intention being to weaken any tumor cells or to deal with any cells outside the range of the radiation. Another major variance in the standard brachytherapy procedures is to combine brachytherapy with EXTERNAL BEAM RADIATION THERAPY (EBRT).

    Positive consequences of brachytherapy:

    • Success or "cure" for radiation treatments is measured by a gradual reduction in PSA level in the months after treatment is completed. The aim is to achieve a nadir, or low point, of 0.200 ng/ml and to maintain that level. Some authorities feel a nadir of under 1.00 ng/ml is an acceptable level. Some men experience what is referred to as a "bump" about 18 months after radiation when the PSA rises and then falls again. The time taken to achieve a nadir varies considerably.
    • No formal studies have demonstrated the superiority of radiation therapy over other forms of therapy, including Active Surveillance in appropriate cases. There is a failure rate of about 30% - 35% over a period of 10 - 15 years for men undergoing radiation therapy. This may appear to be a higher overall rate than for some other therapies. That is likely to be because generally men choosing radiation therapies are older and may have more advanced disease than those choosing other therapies.
    • Cryotherapy can be used as a salvage therapy in the event of failure of initial therapy.

    Negative consequences of brachytherapy:

    Short Term:

    • The entry of needles in the perineum can cause irritation, swelling and inflammation in this and the genital areas. This usually responds to icing and anti-inflammatory drugs.
    • Fluid can also collect in the scrotum, although this is more rare. Medical help should be sought.
    • There may be some itching and burning during urination in the immediate aftermath of the treatment as well as some urgency and blood in the urine. These consequences usually dissipate over a few days. If they do not medical help should be sought.
    • Ejaculate is likely to be affected in volume, texture and appearance. This may revert to a normal ejaculate over time.
    • In the case of SI procedures, seeds may become dislodged before healing is complete and move into the urethra. Cases have been reported of seeds migrating to the bloodstream and lodging in the lungs. This occurrence appears to be rare and it is claimed that it does not involve any danger. The prospect of seeds migrating is negated if the stranding procedure is used. If the seeds are not stranded, it is suggested that a condom be worn after the procedure and urination should be through a mesh sieve until healing is complete.
    • There is some concern in some quarters about the potential of radiation from implanted seeds causing damage to people in close proximity to the man after the procedure. Some practitioners insist on the wearing of lead underpants for the half life of the seeds; others suggest that young children should not sit on the lap of the man during this period; others claim that any residual radiation is less than that experience in an aircraft.

    Long Term:

    • The incidence of Erectile Dysfunction (ED) - the inability to have an erection - is reportedly similar to other therapies. This ED may occur over a period of time, in contrast to surgery where the immediate loss of erectile function may be regained over a period of time.
    • It is highly probable that even if the ejaculate reverts to normality, it will not contain active spermatozoa. Anyone considering radiation therapy who may wish to father a child should consider using a sperm bank prior to the start of the procedure.
    • In the event of recurrence or failure of radiation treatment, surgery is not a good option and is rarely successful because of the damage done to the tissue by the procedure. The usual option for further management is ANDROGEN DEPRIVATION THERAPY (ADT). Although it is claimed that CRYOTHERAPY can also be used as a salvage treatment, this might create complications after brachytherapy. .
    • Most urinary problems that might arise are likely to be short term as listed above, but long term complications of urinary urgency/frequency, difficulty in starting a urine stream and incontinence may arise over time as the radioactivity continues to destroy cells.
    • Radiation therapies can sometimes result in bowel incontinence - the inability to control the bowel - as well as rectal bleeding. The reported incidence of bowel incontinence is fairly low for brachytherapy, but some bleeding may start in the longer term.

    There is a very thorough explanation of the procedure and outcomes in a specific study at BRACHYTHERAPY IN LOCALIZED PROSTATE CANCER. This study is comparatively long term, since it was commenced in 1998 and the median period reviewed is 7.5 years, which is to say that half the men in the study were treated more than seven and a half years ago. A word of warning for this, and any study you might read, the devil is in the detail and the definitions. When it is claimed that the "...percentage is 65% average on preserving sexual function over these 7.5 years." and therefore better than other practitioners, you would need to know precise definitions of what 'sexual function' means in this study.

    For more specific information you may care to visit the SEEDPODS WEBSITE and for an interesting insight into how a decision to opt for brachytherapy was made as long ago as 1996 you can read how Andy Grove went about his research in his article TAKING ON PROSTATE CANCER.

    BACK TO INDEX

    RADIATION - EXTERNAL BEAM

    INCLUDES: CALYPSO®: CYBERKNIFE®: DART®: PROSTRCISION®: PROTON BEAM

    External beam radiation is known by many acronyms - EBR or EBRT being the most common. In this treatment a stream of photons or protons is aimed at the prostate gland. The intention is to damage the DNA of the cancerous cells, leading to their death over time. There is inevitably some risk of damage to the healthy cells in the prostate and the surrounding tissue. To minimize the negative consequences of this collateral damage, the total radiation dose (which is measured in Greys, expressed as Gy) is fractionated i.e. divided into smaller doses. This means that the treatment is spread over a relatively long period, normally once a day, five days a week for seven weeks. However there are many variances to this 'standard', including HYPOFRACTIONATED THERAPIES, where a much greater fraction of a smaller total dose is used at each session. There is a greater risk of collateral damage with these therapies unless the beam is aimed extremely accurately, but since there are fewer sessions, there is a benefit of convenience for the man undergoing the therapy - and increased turnover for the supplier of the service.

    There are many variables that can be very confusing for the newly diagnosed man. This section is subdivided into three sections:

    AIMING BEAMS AND DELIVERY OF DOSES - including references to Calypso®: Cyberknife®: DART®

    PROTON BEAM V PHOTON BEAM

    ADJUVANT THERAPIES - ADT (Androgen Deprivation Therapy); Brachytherapy including reference to ProstRcision® and DART®

    SALVAGE THERAPIES

    • AIMING BEAMS AND DELIVERY OF DOSES

    All EBRT require the man to undergo what is termed a planning session. This is intended to plot as accurately as possible the site of the man's prostate and tumors using CAT or MRI scans. When the older techniques are used, target markers are made on the man's body. These are usually small tattoos. Yana Mentor MARKKU LEITSO wrote an amusing piece about this procedure at MARKKU'S GREAT BIG TATTOO ADVENTURE. The tattoos created aiming points for the radiation beams.

    As time went by there was a recognition that, given the movement of the patient and the gland, a better delivery system was required. This new system was termed 3D conformal beam radiation therapy (known as 3DEBRT, 3DCRT ,3DRT, 3DXBRT and no doubt by other acronyms). Casts were made of the man's body to hold him in the same position for each session. As the radiation heads in the machines became more mobile and accurate - the so called stereotactic heads - proposed trajectories and precise strengths of the multiple beams used in each session were plotted. The term 'conformal' came from this aim to conform to the plotted beams with the man in precisely the same position for every one of the 35 or so sessions. Because there was an increase in accuracy, it was possible to increase the doses delivered without damaging other parts of the body.

    Although the conformal radiation process was a substantial improvement, the beams were still being aimed at the position where the prostate gland had been when the planning session was carried out. It could not take into account the day to day movements of the gland. There are significant movements of the gland caused by the contents of the bladder or bowel for example, or even by breathing which can move the gland as much as 3 cm. This led to the next step in improving aim - what was termed broadly as dynamic adaptive radiation therapy. This INTRODUCTION gives some background on the development of this process.

    Initially, as MRI and CAT scans became more efficient, so called fiducials were introduced into the prostate gland in much the same way as seeds were implanted in the brachytherapy procedure. This was through the perineum, the area between the anus and the scrotum. These fiducials were small metal seeds - usually gold because it is inert - which showed up very clearly on scans. They were then used as aiming points, initially before the start of each session and later in real time when the scanners were linked to the radiation equipment.

    This new procedure was termed generally as IMRT (Intensity Modulated Radiation Therapy) or IGRT (Image Guided Radiation Therapy). A number of institutions created trademarks to describe their versions of therapies using what were termed dynamic adaptive radiation therapy. Two of the better known ones are CyberKnife® and DART®. The next step was the development of the Calypso® 4D process. This takes the fiducials aiming points one step further by the implant of what might be termed GPS devices. Very small electronic seeds that signal their position and thus do away with the necessity of scanning equipment being used. Oregon Health Sciences University followed RICK DANCER through his treatment to show men what Calypso Radiation is all about. Rick feels that if you are looking at this form of treatment, this VIDEO SERIES may help you.

    These advances make it even more difficult to compare the outcome of old EBRT procedures with modern ones. All that can be said in broad terms is that the newer procedures are a very significant improvement over the older ones. The most important question a man considering EBRT can ask is how the beams will be aimed and monitored to ensure an accurate delivery, especially if a hypofractionated dosage is planned.

    • PROTON BEAM V PHOTON BEAM

    Although there is only one letter difference between proton beam therapy and photon beam therapy, advocates of the latter believe that there is a substantial difference in the consequences.

    Most men do not have the relevant ability to fully understand and evaluate the difference between the therapies based on these options. At a very basic level it can be said that photons (more commonly known as X-rays) are electromagnetic waves that have no mass or charge. Protons are large, positively charged particles.

    Where the critical difference lies is that photon beams aimed at a tumor in the prostate gland not only penetrate and act on the tissue they pass through on the way to the target, they then continue through the target and the tissue beyond that. To minimize damage to tissue on each side of the prostate gland the proton beams are fractionated and beamed from a variety of angles through the stereotactic heads. These beams cross in the gland. That means that the gland gets the full dose aimed at it, while other tissues gets smaller doses which do less damage.

    Proton beams on the other hand can be controlled as to the depth of penetration. They deposit a large share of their dose in the “Bragg peak” over a relatively short distance close to the end of the particle’s track in tissue. Beyond the Bragg peak, which is managed by the relative energy of the beam, protons deliver almost no additional exit dose. The ability to 'stop' the beam at the prostate gland means that tissue beyond the gland is spared large doses of radiation. This would allow proton beams to effectively spare critical structures that are located very close to the target. This is a simplistic lay person's understanding of these processes. There is far more complex information available on the Internet. Some links are provided below.

    THE NATIONAL ASSOCIATION FOR PROTON THERAPY has further information and you can find the clinics offering proton beam therapy in the United States of America on the site. Men who are not insured or whose insurers will still not pay for PBT will discover that it can be a very expensive option. Men who wish to have proton beam therapy but are uninsured might consider the NATIONAL CANCER CENTRE IN SEOUL, KOREA An eight-week course of proton treatment there costs $54,000, still a large sum for most people but less than the US centers. There is a Proton Beam facility in South Africa - iTHEMBA but it seems that this is not yet used for prostate cancer. A facility is being constructed in Australia and it is said it will be ready early in 2014 - details are at PROTON THERAPY AUSTRALIA. This site also gives news about proton beam sites around the world.

    There is a significant issue in the background of proton beam therapy which may be worth understanding. The procedure was been used for many years on a variety of tumors - notably brain tumors but historically, there was only one institution that used the procedure for prostate cancer. That was LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) in California. The procedure was regarded as 'experimental' by many insurers who declined to pay the cost of the therapy, which was said to be very much higher than standard photon beam therapy. Undertaking the treatment regimen at Loam Linda meant that men had to take up residence for the seven weeks of the treatment. Arrangements were available for suitable accommodation and for sporting and other activities aimed at helping the men through the process of dealing with a potentially fatal disease. This resulted in men developing a collegiate attitude to their time at LOMA Linda, with many speaking highly of the experience. One of the consequences of this attitude is that it seems that any criticism or negativity about the therapy may be dampened. Men who have had the treatment have formed what they call the BROTHERHOOD OF THE BALLOON. Over 2,000 former proton patients participate on the site. One of these men - FULLER JONES - has A STATUS SUMMARY - MARCH 2008. There is also a highly recommended book written by Robert J. Marckini entitled YOU CAN BEAT PROSTATE CANCER AND YOU DON'T NEED SURGERY TO DO IT.

    Claims have been made that the success rate with proton beam therapy is better than photon beam and that the negative consequences are lower. It is difficult to find long term data, independently reviewed that demonstrates these claims. Proponents of proton beam therapy for prostate cancer point to the number of generators that have been built at a very high cost over the last decade. They say this demonstrates the efficacy of the therapy. Opponents of proton beam therapy are of the view that the higher income from this procedure is the driving force behind the wider availability of the therapy. This is a commentary which followed the release of data fifteen years after Loma Linda started using proton beam for prostate cancer: FIRST DIRECTLY COMPARATIVE DATA QUESTION SAFETY OF PBRT VS. IMRT

    • ADJUVANT THERAPIES

    Adjuvant therapies are those that are used in conjunction with the main therapy in the belief that they will make the main therapy more effective. Such additional therapies are termed neo-adjuvant if they are used prior to the main therapy commencing.

    The most common adjuvant therapy used in conjunction with EBRT is ADT (ANDROGEN DEPRIVATION THERAPY) This is sometimes used as a neo-adjuvant therapy (therapy used before the main treatment) to reduce the size of the gland or because there is a belief that the changes to the cancer cells in the gland as a result of the ADT will make them more susceptible to damage by the radiation beams. ADT given after radiation is intended to take care of any cancer cells that were not in the direct path of the radiation beams but were still in the immediate vicinity of the gland.

    The other major adjuvant therapy is the combining of EBRT and brachtherapy. Although this double dose approach is carried out in many institutions, two well known ones are those which have registered trademarks - PROSTRCISION® and DART®. It is important to be aware that the claims made on these sites may not be supported by good independent studies. Advertising claims in the USA are not as subject to strict rules as in other countries. Anyone considering choosing therapies such as these should look for other views. For example Dr Chodak has a warning about ProstRcision in this video BEWARE OF MISLEADING INFORMATION while an interesting commentary WONDEROUS SURVIVAL DATA IN LOW-RISK MEN TREATED WITH PROSTRCISION was published in October 2012 after data was finally released about this therapy.

    Dattoli Cancer Center registered their version of the combined EBRT/brachytherapy process as an acronym of the term Dynamic Adaptive Radiation Therapy, although this term applies to many other variations of radiotherapy as discussed above. There are no such commentaries at this time on DART® because there have been no substantive independent studies to test the claims on the Dattoli Cancer Center site. One study referred to on the site is in respect of men treated between 1992 and 1997. This was before DART® was developed. There have been many changes in the delivery of radiotherapy since then. A Google search shows that almost every reference to DART® is on the Dattoli website or generated by them.

    As is the case with every aspect of prostate cancer, there is no agreement on the precise value of adjuvant therapies.The AUA (American Urological Association) and ASTRO (American Society of Radiation Oncology) released revised guidelines regarding the application of adjuvant radiation therapy in May 2013. You can read them here ADJUVANT AND SALVAGE RADIOTHERAPY AFTER PROSTATECTOMY: ASTRO/AUA GUIDELINE.

    • SALVAGE RADIATION THERAPY (SRT)

    Many men, in making their treatment choice (especially when choosing surgery) take into account the view that, in the event of their primary therapy failing, EBRT is available as an optional so-called 'salvage therapy. The concept behind this is that, if the disease has escaped from the prostate gland, it may not have ventured past the organs in the immediate vicinity of the gland and therefore radiating this area may provide the further probability of 'cure' or long term regression.

    The decision to choose radiation after apparently failed surgery is not an easy one, if only because there is no clear definition of how to define failure. This paper NINE DECISIONS BEFORE ELECTING RADIATION THERAPY AFTER RADICAL PROSTATECTOMY may be helpful in making this difficult decision. It also contains information that might be of interest to anyone consideration EBRT. The AUA (American Urological Association) and ASTRO (American Society of Radiation Oncology) released revised guidelines regarding the application of SRT (Salvage Radiation Therapy) in May 2013. You can read them here ADJUVANT AND SALVAGE RADIOTHERAPY AFTER PROSTATECTOMY: ASTRO/AUA GUIDELINE.

    The consequences of radiation therapy are usually not seen immediately. They tend to develop over time. In typical cases it may be two to three years before all the consequences are fully developed.

    Positive consequences of external beam radiation:

    • Success or "cure" for radiation treatments is measured by a gradual reduction in PSA level in the months after treatment is completed. The aim is to achieve a nadir, or low point, of 0.200 ng/ml and to maintain that level. Some authorities feel a nadir of under 1.00 ng/ml is an acceptable level. Some men experience what is referred to as a "bump" about 18 months after radiation when the PSA rises and then falls again. The time taken to achieve a nadir varies considerably.
    • No formal studies have demonstrated the superiority of radiation therapy over other forms of therapy, including Active Surveillance in appropriate cases. There is a failure rate of about 30% - 35% over a period of 10 - 15 years for men undergoing radiation therapy. This may appear to be a higher overall rate than for some other therapies. That is likely to be because, generally, men choosing radiation therapies are older and may have more advanced disease than those choosing other therapies.

    Negative consequences of external beam radiation:

    Short Term:

    • Because EBRT procedures (other than hypofractionated procedures) take place on a daily basis over many weeks there is some disruption to familiar routines. If proton beam is chosen, it may be necessary to relocated for the time of the therapy because the number of providers is limited.
    • The most common short term consequence of EBRT is a feeling of fatigue which often grows as the therapy progresses. Most men do no seem to be badly affected and a nap usually overcomes the feeling. The fatigue will usually disappear after completion of the therapy.
    • Existing bladder problems may be worsened and urinary retention may be an issue as the gland swells. In few, but severe cases, catheterisation may be required. It is for this reason that men with existing problems are counseled against radiation as an option.
    • There may be some bleeding in the rectal area although this is unusual with modern procedures.

    Long Term:

    • The incidence of Erectile Dysfunction (ED) - the inability to have an erection - is reportedly similar to other therapies. This ED usually occurs over a period of time, in contrast to surgery where the immediate loss of erectile function may be regained over a period of time. Because historically men who opted for radiation therapy tended to be older or more sickly than men who chose surgery, some of the reported ED may be due to the aging process.
    • Ejaculate is likely to be affected in volume, texture and appearance. It is highly probable that even if the ejaculate reverts to normality, it will not contain active spermatozoa. Anyone considering radiation therapy who may wish to father a child should consider using a sperm bank prior to the start of the procedure.
    • In the event of recurrence or failure of radiation treatment, surgery is not a good option and is rarely successful because of the damage done to the tissue by the radiation. The usual option for further management is ANDROGEN DEPRIVATION THERAPY (ADT). It is claimed that CRYOTHERAPY can also be used as a salvage treatment.
    • Most urinary problems that might arise are likely to be short term as mentioned above, but long term complications of urinary urgency/frequency, difficulty in starting a urine stream and incontinence may arise over time.
    • Radiation therapies can sometimes result in bowel incontinence - the inability to control the bowel - as well as rectal bleeding. The reported incidence of bowel incontinence is fairly low where modern equipment is used, but some bleeding may start in the longer term.
    • There is some evidence that EBRT may be associated with the development of other cancers, notably bladder cancer. The studies to date show a very small risk of this consequence.

    BACK TO INDEX

    SALVESTROLS

    Dr Gerry Potter is credited with the discovery of Abiraterone Acetate which has been approved a a therapy for prostate cancer and is now marketed under the trade name of ZYTIGA. He now claims that he has discovered another compound which he has named Salvestrols.

    A paper titled NUTRITION AND CANCER: SALVESTROL CASE STUDIES has four authors, including Dr Potter. The Introduction says how Salvestrols work and says in part

    "Salvestrols are a class of phytonutrients that, in humans, are metabolised by the tumourspecific CYP1B1 enzyme in cancer cells to initiate a cascade of processes, including apoptosis, that result in the arrest or decline of the cancer…………. We use them in helping to rid our body of cells that have become cancerous."

    The claims made are then supported by reference to what are termed 'Cases'. Case #3 is Prostate Cancer and states:

    A seventy-four-year-old gentleman received a PSA test result indicating a level of 11 ng/ml in the blood following his annual check-up. His previous PSA result had been 4 ng/ml. The consulting surgeon suspected cancer and advised that surgery or radiation would be required. A follow-up magnetic resonance scan and full body X-ray confirmed a diagnosis of prostate cancer. Surgery or radiation were both ruled out and the patient was prescribed a course of the synthetic hormone leuprorelin acetate (Prostap®) on a quarterly basis. The patient was advised that this treatment would be required for the rest of his life.

    Subsequently this gentleman spoke with his cousin, a university lecturer, who told him that one of his students was diagnosed with a terminal cancer of the brain and after taking Salvestrols had proved to her doctors that 'terminal' seemed to be an overstatement. He decided to begin a course of Salvestrol supplementation taking two (350 point) Salvestrol Professional capsules per day.

    Six months after receiving his diagnosis his PSA level had dropped to below 1 ng/ml. However, during this time the patient suffered from breast development, complete loss of body hair, impotence and a complete lack of libido as a result of the synthetic hormones. The patient moving to another country necessitated a change of doctors. At this point the patient switched Salvestrol products and began taking one (1,000 point) Salvestrol Professional capsule per day and one (350 point) Salvestrol Professional capsule three times per day. Twelve months after receiving his diagnosis his PSA level had dropped to 0.2 ng/ml.

    The new doctor continued with the PSA monitoring and quarterly injections of Lupron (a different brand of leuprorelin acetate). Upon receiving a subsequent PSA test result for this patient the attending physician said that the PSA level received was as low as it could be and asked if the patient was sure that he had not had surgery! Given the physician's surprise that such a result could be attributed to leuprorelin acetate alone the patient confessed to taking Salvestrols. The physician then stated that he had a patient that he would like to start on Salvestrols and asked the patient to supply him with background information. The physician decided to 'wean' the patient off of the quarterly Lupron injections.

    This patient has not had a Lupron injection for six months and continues to receive PSA test results at the 0.2 ng/ml level. The patient continues to take one (350 point) Salvestrol Professional capsule per day and has embarked on a fitness program and change in diet.

    There is a deal of misleading information here:

    1. At least 65% of men with a PSA of 11 ng/ml will not have a positive biopsy. The most common causes of PSA readings at this level are BPH (Benign Prostatic Hyperplasia) and prostate/bladder infections
    2. It is not possible to diagnosed prostate cancer without a biopsy procedure: a follow-up magnetic resonance scan and full body X-ray cannot confirm a diagnosis of prostate cancer.
    3. It is difficult to establish a time range for this study, but it would not be unusual for a PSA of 11 ng/ml to revert to a 'normal' very low level if it was due to BPH (Benign Prostatic Hyperplasia) following ADT (Androgen Deprivation Therapy) for what appears to be at least eighteen months

    For these reasons it seems appropriate not to accept that this constitutes a 'proof' that Salvestrols have 'cured' this man.

    For more on the subject, go to TRADEMARKED SCIENCE TRADE-OFFS. If you do that, please read the comments, which present some other relevant information.

    Positive consequences of active salvestrols:

    • Salvestrols may well improve overall health. This may then enhance the immune system to such an extent that the cancer is sent into regression.
    • The consequences of conventional therapies may be lessened or managed better by using Salvestrols.

    Negative consequences of active salvestrols:

    • The use of Salvestrols may clash with conventional medication. For this reason, the use of Salvestrols should always be discussed with medical advisors before commencing the therapy.
    • There is no clear evidence for the efficacy of Salvestrols in managing prostate cancer.
    • Relying on Salvestrols can result in the disease advancing to a stage where any prospect of cure by conventional means is lost.

    BACK TO INDEX

    SURGERY

    OPEN MANUAL RADICAL: RETROPUBIC PROSTATECTOMY: PERINEAL PROSTATECTOMY

    LAPAROSCOPIC : MANUAL: ROBOTIC ASSISTED (RALP) - DA VINCI

    Most men diagnosed with prostate cancer choose surgery. This is especially true in the US where surgery is often referred to as the 'gold standard' of all the optional therapies and choices. It is the treatment most commonly prescribed for younger men or early stage prostate cancer. The traditional surgery was an 'open' procedure but there is enormous and rapid growth in laparoscopic - 'keyhole' - surgery, especially the Da Vinci robotic assisted procedure. There is some disagreement as to whether it is always in the best interests of men with what is termed LOW RISK prostate cancer to have surgery before spending time trying to establish if the disease is one of the indolent types or the more aggressive types.

    Prostate cancer surgery - radical prostatectomy (RP) - is a complex operation and there are four main optional procedures: two open procedures and two laparoscopic. This technical document ANATOMICAL APPROACH TO RADICAL PROSTATECTOMY gives some idea of the major steps in the procedure. Mayo Clinic announced a new procedure termed NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY (NOTES) and removes the prostate gland through the penis in July 2010. It is difficult to see the advantage of this, which seems to make a complex procedure even more complex. Apparently there are alternative, but similar procedures, one of which uses some form of microwave and another that removes the gland through a small incision in the belly to give access to the bladder. These would all be regarded as experimental.

    In open surgery, the prostate gland is reached either from the lower part of the front of the body - this is a retropubic procedure - or through the area between the anus and the scrotum - this is a perineal procedure. The illustration shows where the incisions are made in these two procedures. Historically, the perineal approach was less common than the retropubic. There are no studies that show either of these procedures to be superior to the other but several claims were made for each. One of the key claims for retropubic was that it made for easier access to lymph nodes to check for progression. It is now very unusual to carry out this check. The supporters of the perineal approach claimed that there was less chance of blood loss with this option. Historically the retropubic operation did indeed involve a substantial loss of blood. Some surgeons recommend the drawing and storing of the patient's own blood ahead of the operation as a precautionary measure. However, the significant improvements in surgical techniques have made it unusual now for a transfusion to be required.

    Laparoscopic surgery on the other hand requires five small ( five to 10 millimeters) incisions (or portholes), one just above or below the belly button and two each on both sides of the lower abdomen. Four arms are inserted into the portholes, three hold instruments, the fourth holds the camera - this is the laparoscope which enables the surgeon to get pictures of the prostate on a video monitor. Manual laparoscopic procedures have been described like operating with knitting needles. The arms used are straight rods which make it difficult in some cases to reach the entire gland, given the variability in size and precise placement of the gland in the body. The arms used in the robotic assisted procedure are flexible and this restriction of reach would only apply in unusual cases.

    In laparoscopic prostatectomy, the man is positioned in the so-called Trendelenburg position, with spread legs and feet higher than the head. This slight slant shifts the organs located in the abdomen towards the head, which provides the surgeon with more room in the pelvic area. Carbon dioxide is passed into the abdominal cavity through a small tube placed into the incision below the belly button. This gas lifts the abdominal wall to give the surgeon a better view of the abdominal cavity once the laparoscope is in place. The operating arms are used by the surgeon to remove the gland, through one of the portholes. When the procedure is robotic assisted - the so-called Da Vinci procedure - the surgeon sits at a console away from the operating table. He views the procedure by looking at the 3-D images from the laparoscope. The operating arms are maneuvered with two foot pedals and two hand controllers, translating the the surgeon's movements into precise micro-movements of the instruments.

    RP (radical prostatectomy), whether open or laparoscopic, is a major surgical procedure and will usually take 3 - 4 hours. Discharge from hospital was historically within 3 to 5 days for the 'open' procedures but is now likely to be 2 or less. Laparoscopic surgery, on the other hand, is far less traumatic and men are usually discharged from hospital in 24 hours. There is still a good deal of disagreement about the merits of the two procedures. Surgeons favoring open surgery say that they can feel the prostate and get a better idea of where the tumor might be and thus have more assurance of negative margins: doctors favoring laparoscopic surgery say that the better view obtained through the magnifying lens enables them to cut and stitch more accurately. As yet there are no long term studies to support either view. Commentaries on some relevant studies, which are linked from the commentaries, published since 2010 are listed below. It appears that the incidence of initial negative consequences with laproscopic procedures are similar to those with open procedures, as are early biochemical failure rates.

    Vattikuti Urology Institute October 2010: 5-YEAR OUTCOMES OF PATIENTS TREATED WITH RALP

    European Urology March 2011: QUALITY OF OUTCOMES AFTER FIRST-LINE RP

    Journal for Healthcare Quality July 2011: ARE CLINICAL BENEFITS OF RALP BEING OVER-HYPED?

    Massachusetts General February 2012 : RALP NOT ASSOCIATED WITH BETTER CONTINENCE, SEXUAL FUNCTION

    European Urology April 2012: SHORT-TERM OUTCOMES OF RALP COMPARED TO OPEN SURGERY

    European Urology October 2012: CONTINENCE AND SEXUAL FUNCTION AFTER RALP COMPARED TO LRP

    One thing has become clear - the learning curve for the laparoscopic procedure is a long one. One published study implies that it takes at least 250 procedures before the surgeon can be regarded as proficient. Once a decision has been made to proceed with surgery and which optional surgical procedure is likely to produce the best result, the next step is the selection of the surgeon to carry it out. There is evidence that the expertise of the medical team carrying out a procedure has a direct bearing on the likely outcome. The more experienced the surgeon, the less the likelihood of negative consequences. Dr Arnon Krongrad is a prostate cancer surgeon. He has written a piece which may help in finding the right surgeon: HOW TO PICK A PROSTATE CANCER SURGEON - the same principles would apply to choosing any medical team. Two long term survivors of the disease maintain lists of what they term the best surgeons and specialists. Contact details are on the RESOURCES page.

    Positive consequences of surgery:

    • Surgery can introduce an element of certainty. The entire prostate gland can be examined closely to establish the extent of the tumor, to verify the Gleason Score and to clarify the likelihood of the tumor being contained within the gland.
    • If there has been no spread beyond the gland, then the removal of the prostate should, by definition, remove the tumor For many men that is of utmost importance.
    • In the event of recurrence or failure, it is possible to use EBRT (EXTERNAL BEAM RADIATION THERAPY) as what is termed a salvage therapy to treat recurrence thought to be confined to the prostate bed, or to use ADT (ANDROGEN DEPRIVATION THERAPY) as a secondary treatment for recurrence where the disease has spread into other areas of the body. There are also claims that CRYOTHERAPY can be used for salvage therapy.

    Negative consequences of surgery:

    Short term:

    • The most significant negative consequence of of surgery is erectile dysfunction (ED - the difficulty or inability to have an erection). This comes about because the nerves controlling erections are embedded near the surface of the prostate gland; one set on each side. Short term ED occurs in almost 100% of men immediately after surgery, but will improve in many men as time goes by. There is a view that the use of drugs or injections to stimulate erections as soon as is safe after surgery may help to improve the long term outcome - see USE IT OR LOSE IT. Recovery of erectile function will almost certainly take many months and sometimes a year or more. Recovery of erectile function is dependent to a large extent on the ability of the surgeon to spare the erectile nerves, although this is not the only factor.
    • Bladder incontinence (the inability to control the bladder) is the second most significant negative consequence. A catheter will be in place, usually for some weeks after the surgery. It normally takes some time - typically about three months, although this can vary considerably - to regain control of the bladder function.
    • There may be some short period shoulder and neck problems after surgery in the Trendelenburg position, especially if there is a pre-existing condition which may be exacerbated by having the body in this position.
    • There is often a considerable degree of discomfort with gas, which is why men are encouraged to start walking as soon as they can do so in comfort. As is the case with horses, such movement helps in releasing the gas. There is a view that the carbon dioxide used in some procedures is the cause of this problem, but the expert view is that the unusual angle of the body for some hours traps normal gas in the gut.

    Long term:

    • The Gleason Score established after examining the entire gland may differ from the biopsy score. About one third will be found to be higher and about one third lower. Dr. Peter Scardino, author and specialist at Memorial Sloan-Kettering was quoted as saying that there was no guarantee that surgery would actually find cancer. He said in part [MSK] "...... looked at 2,000 patients whose prostates were removed during the last four years, after biopsies said they had cancer. But in more than 30% of the cases, the prostate removed either had microscopic amounts that weren't life-threatening, or no cancer at all.....in some cases, cells removed in biopsies were cancerous, but the rest of the prostate appeared cancer-free."
    • The finding of no positive margins is taken to show that the disease has not spread beyond the prostate gland. Success or "cure" is measured by taking PSA tests at intervals after the surgery. Ideally there should be no PSA measurement detectable with the normal PSA test. ULTRA-SENSITIVE PSA tests may show very low levels - well below 0.10 ng/ml.
    • No formal studies have demonstrated the superiority of surgery over other forms of therapy, including Active Surveillance, in early stage cancer. There is a failure rate of about 30% - 35% over a period of 10 - 15 years for men undergoing surgery. Some failures have been reported at 20 years. In the event of recurrence or failure of the treatment, it is possible to use EBRT (External Beam Radiation Therapy) to treat recurrence thought to be confined to the prostate bed, or to use ADT (Androgen Deprivation Therapy) as a secondary treatment for recurrence where the disease has spread into other areas of the body.
    • There are claims of a reduction in the reported rates of long term ED (erectile dysfunction) following the development of what is referred to as the "nerve-sparing" technique and the use of pharmaceutical drugs such as Cialis, Levitra or Viagra or one of the injectable materials - MUSE, Tri-Mix and the like. However, the position of the tumor may affect the ability of even the best surgeon to spare one or both of the nerves while removing all the cancer. The long term ED rate is still high - probably over 50%, especially for men over the age of 50. Studies quoted with better rates should be examined very carefully, especially for definitions of potency or erectile function. One recent study defined satisfactory recovery of erectile function as "...the ability to achieve and maintain satisfactory erections firm enough for sexual intercourse in more than 50% of attempts, with or without the use of drugs like Viagra or Cialis or Levitra." The published studies usually involve excellent surgeons and may not reflect the general outcome of surgeries carried out by surgeons with less experience.
    • Long term total bladder incontinence is reported in a small number of men - about 5% - but many men experience some leakage when lifting, coughing, sneezing or laughing. Again it is important to look at definitions in studies showing levels of continence after treatment. It is not uncommon for the use of 'only' one or two pads a day to be regarded as fully continent in such studies. The outcomes of surgery carried out by urologists who do not have the experience of surgeons in a centre of excellence are usually worse than the results shown in published studies.
    • CLIMACTURIA - the leakage of urine at climax for men who are able to achieve sexual activity after surgery is not discussed very often on prostate cancer sites and this can lead men to believe that they are one of the few men to have this problem. One study suggests that 50% of men may have to deal with this issue.
    • PENILE SHRINKAGE is also reported in a significant number of men, thought to be the result of maintaining the penis in the flaccid state during what can be many months of recovery of erectile function. It is thought this can be counteracted by stimulating erections with drugs or manual devices as soon as post-surgical healing has taken place.
    • PEYRONIES DISEASE or Peyronie's Syndrome occurs in a surprising number of men who have had surgery. This condition is one where the erect penis acquires a 'bend' or deflection. The vast majority of Peyronie cases are very mild but others can cause severe problems. It seems unlikely that the condition is directly caused by a disease, or that it has any direct link with prostate cancer. A common cause is thought to arise from accidents during sexual activities, especially if the penis is not fully erect.
    • Stricture from scar tissue can also cause long term urinary problems. If the man has a history of poor scarring (some reports suggest that if any scar on his body is more than 10 mm (about 3/8") wide) then there is about an eightfold increase in urinary problems following RP (Radical Prostatectomy).
    • Since there is no ejaculate following the removal of the prostate gland men are infertile, although it may be possible to recover spermatozoa from the testes. Men intending to father children should consider banking sperm before surgery.

    Men choosing this option might find it helpful to visit these links:

    Another aspect of Surgery that often causes some concern ahead of the procedure is the likely effect on sexual ability. These are three pieces written by men based on their personal experiences that might be useful reading:

    SEX AFTER RADICAL PROSTATECTOMY

    SEX AND PROSTATE CANCER

    ERECTIONS - WHAT MOST MEN WON'T TALK ABOUT BUT THEY ALL WANT TO KNOW ABOUT

    Husband and wife team Stephan Wilkinson and Susan Crandell contributed their views on erectile dysfunction for a book OVER THE HILL AND BETWEEN THE SHEETS: SEX, LOVE AND LUST IN MIDDLE AGE after Stephan's radical prostatectomy. These excellent pieces written by them show clearly some of the differences between the way men and women regard the issue and are well worth reading.

    Susan's essay is WHAT'S SEX GOT TO DO WITH IT? and

    Stephan's is entitled MECHANICAL FAILURE.

    Sex therapist Bettina Arndt collected data from a number of men on the site for her book WHAT MEN WANT - IN BED is all about why sex matters so much to men

    BACK TO INDEX

    ZYTIGA : ABIRATERONE

    Abiraterone was approved by the US Food and Drug Administration (FDA) in April 2011. The trial used to gain approval was for men with late stage metastasized prostate cancer which was castration-resistant (also know as hormone-resistant or hormone-refractory prostate cancer) which had not responded to chemotherapy. For commentary on a trial in men who had not yet used chemotherapy see ABIRATERONE ACETATE IN CHEMOTHERAPY-NAIVE MCRPC - PHASE III TRIAL OUTCOME. Abiraterone is marketed under the trade name Zytiga in combination with prednisone or prednisolone. There are no studies to indicate what the long term consequences are of taking Zytiga. The short term approval studies show the following consequences:

    Positive consequences of Zytiga:

    • An extended median survival of 14.8 months against the 11.2 months of the men on a placebo.
    • A decline in prostate specific antigen (PSA) in up to 70% of patients as well as some shrinkage of tumors and some symptom improvement.

    Negative consequences of Zytiga:

    • It is extremely important to follow strict rules in taking Zytiga. No food should be eaten two hours before and one hour after taking the daily dose.
    • Heart Problems: High blood pressure (hypertension), low blood potassium levels (hypokalemia), and fluid retention (edema). Men with existing heart problems must present a full medical history before considering Zytiga.
    • Liver problems: Blood tests to check liver function must be carried out before and during treatment.
    • Minor issues include: Joint swelling or pain; Muscle aches; Hot flushes; Diarrhea; Urinary tract infection; Cough; Irregular heartbeats; Urinating more often than normal/need to get up at night to urinate; Heartburn; Cold-like symptoms; Bone fractures.
    • Adrenal problems may occur.

    Studies are being undertaken to evaluate the use of Zytiga by men who do not yet have metastasized or castration-resistant disease. One small short term study looks promising.

    BACK TO INDEX

    The last of the pages in this section of the site is next - RESOURCES. There you will find links to other sites where you can find more detailed and varied information. All this should give you a better understanding of your diagnosis and help you make the decision that is best for you.

    RETURN TO HOME PAGE LINKS