Good idea to be in a clinical study?

tarhoosier said:

Carolyn, for him
If you and/or your friend go to the UK site here:

http://forum.prostate-cancer.org.uk/forums/

and ask about STAMPEDE you will find some participants and several conversations about the trial.

The site may require registration which is free. It s an active, peer to peer site with many interesting threads.

VascodaGama said:

Trials or RT+HT
Carolyn

Welcome to the board.

In answering your question, I should say that YES it is a good idea to get into a clinical trial.
These trials are well organized and safe and provide patients with an opportunity of getting drugs which have proven success but are restricted due to established regulations (FDA’s approvals of use) in certain type of patients. Many doctors go “off-label” when they know that the drug is good but not approved for the practice.

In the case of “stampede”, it includes several well known drugs so that your friend may choose in which to participate. Nevertheless, trials usually have minimum requirements in which your friend’s status must fall.

The protocols of each group should be described firstly. Pointed by you, the group 1 (the placebo) is the minimum that your friend requires at his present status, which may be what he is already getting; the LHRH agonist (Decapeptyl) plus the antiandrogen (Cyproterone). It could also be added with a 5-ARI drug similar to Avodart which would help the antiandrogen to “perform” better. Apart of that, the antiandrogen should be taken continuously not only during the first 28 days, you describe.

Adding to this protocol your friend will require medication to his bone metastases which is not included in any other Group of the trial. However, the Group 2 adds Zometa which is an bisphosphonate known to repair bone loss and reverse the effect of cancer in bone to a certain extent. This drug, although, got its own side effects the most common being osteonecrosis of the jaw. See this for details;
(http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/onj.asp)

Better than Zometa would be a drug like Xgeva (denosumab), that is known to attack cancer at the bone and relieve pain. (http://www.xgeva.com/)

The Group 3 and 4 include in the protocol chemo drugs which may be too earlier for your friend. After failure of hormonal therapy that is usually the course to take. Nevertheless, some doctors recommend starting chemo before a patient becomes hormone refractory.

The Group 5 includes a “miracle” drug (Abiraterone acetate) which may be the best “shot” at the treatment of prostate cancer nowadays. Abiraterone would substitute the antiandrogen (Cyproterone) in the initial protocol. In other words, it is like a “modern” protocol in hormonal treatment. However, abiraterone has its own pitfalls and some guys cannot metabolize the drug well, causing it to be prohibitive.
That is the drug that I am aspiring to take on my second term on HT (if needed) after a must wanted “vacations” period on my intermittent protocol (IADT).

Another successful drug which have shown high curative effects (100%) in PCa bone metastases is Alpharadin (radium 223) which has been on trials (phase 3) under the acronym ALSYMPCA. Your friend could consult his oncologists to check for a possibility to participate, if he wants to give it a try.

If not trials, your friend may benefit from a protocol with radiotherapy done in combination with HT. I would recommend you to do some researches on what is called Oligometastatic cancer. This is a situation when just few spots of cancer are present and in a trasactional status before the cancer spreads and advances to become systemic. This diagnosis gives a chance of cure if one can radiate those spots.
You can read details and listen to the video presented by the famous oncologist Dr. Charles Myers in his site. (http://csn.cancer.org/node/227924#comment-1136201)

A good book I recommend for your friend is; “Beating Prostate Cancer: Hormonal Therapy & Diet” by Dr. Charles “Snuffy” Myers; which informs on diagnosis and treatments for cases similar to your friend.

I am very much interested in knowing details of that “....new targeted treatment for prostate cancer that has few to no side effects that will be available within the year.” You commented above.

Wishing you and your friend the best in your cases.

VGama

VascodaGama said:

Too Young to Give up
Carolyn

The info you shared on your friend is not sufficient for guys here to give you due advices. His present health status and life expectancy are important factors in the decision for a postponement of a treatment. It is common to read comments on the limit age of 75 to treat a patient with “intent at cure”. This is because males at 75 are expected to live at least ten years to the age of 85.
At 74 years old your friend may postpone a radical treatment but he is not too old for palliative therapies such as HT. Surely this is a very private opinion and only he can decide on what to do.

Prostate cancer is a slow type when comparing it with other cancers but it kills and the death seems to be painful and nasty. Some guys prefer to do nothing and wait for the death while managing pain. However, in your friend’s case it seems that he still has wide possibilities of control and maybe of cure, I would never recommend him to give up.

Hormonal treatment is a palliative way for the control of the cancer. It does not cure but it can extend the period of control during many years, in some cases over 12 years. HT should not be mistaken with chemotherapy. The risks and side effects are must lesser and mild, and in some guys they tend to be less accented (a sort of menopause symptoms). In any event, your friend’s present status and diagnosis will rule if in fact HT would do him any good.

The PSA at 60 is high but without knowing his past PSA chronology along the 14 years, his Gleason score, pathological stage and data from the pathologist’s report after surgery on the type of cancer; the “just two spots” is hardly enough to judge his case as an indolent type so that he will die from other causes.

Your descriptions on the reasons for a postponement are totally sense less to me.

“.....he's rather frightened by the possible side effects and having to drive 25 miles to the hospital every week or perhaps more. (Gas is about $9 per gallon, plus the Highland winter storms can be rather vicious.) Of course he wants to live and doesn't know if he is passing up on something that would prolong his life. MY thought is that since it has been 14 years since surgery and he has only 2 teensy spots on his bones, the added treatment could be overkill ....”

Hormonal treatment does not require weekly visits to the hospital. Chemo may require such.
I am on HT since November 2010 and have met my doctor only two times in one year. I am also a survivor from surgery (RP) done eleven years ago (2000). I am younger than your friend (now at 62) but I am hoping to pass my 80th with a control on the bandit.
The side effects from the hormonal drugs have been mild to me. I believe that such is due to my regimen in changing my life style, on diet and physical fitness (daily walks, golf on week-ends and gardening).

Your friend can do it too. He needs an oncologist that he can trust, educate himself on the matters of prostate cancer and probably take part on cancer community events.

In my opinion he should continue with the hormonal treatment (LHRH agonists plus continuous Cyproterone acetate 50 to 100mg/day) and check for the results using the PSA test and a testosterone test done every three months. In case of failure he then should consider to substitute the Cyproterone by Abiraterone. It can take years to do so.

Please note that I am not a doctor. Your friend should inquire with his doctor on the above and only follow his instructions. Certain drugs interact with each other (drugs for other illnesses) prohibiting some protocols.

Here is a book that may help him in prepare a long list of questions for his next meeting with the doctor;
100 Questions & Answers about Prostate Cancer, by Alan J. Wein and Pamela Ellsworth.

Wishing him luck.
Happy New Year

VGama