PSA Rising on Hormone Therapy? Here are 2 Interesting Clinical Trials – Take a Look. By Jan Manarite, VP of Advocacy & Education
Every clinical trial is different. It’s almost impossible to get clear and understandable information regarding clinical trials, which in turn would enable a patient to decide whether or not they even want to consider participating in a trial. Here are 2 trials that looked interesting to me that I thought patients might like to know about. These trials are for men who are not metastatic, but have PSA recurrence while on hormone therapy.
Not all clinical trials have placebo, so always look closely at that information. These 2 trials do have a placebo, BUT in 1 trial, if your cancer progresses on placebo, you are offered free Zytiga, so there’s almost no risk to the patient. In both trials, 2/3 of the patients receive the trial drug and 1/3 receive placebo.
Also, remember that these 2 drugs are not available anywhere in the market – only in these clinical trials. So you may be giving your prostate cancer a great advantage by allowing it to be exposed to these drugs early on. It will probably be several years before these drugs make it to market since the research process takes so long. These clinical trials are really worth considering, so talk to your physician(s) and nurse(s) after reading the Basic Eligibility Criteria below.
These 2 trials are pills that are Second-Line Hormonal Therapies, not chemotherapy. They are for men who are NOT metastatic, but have a rising PSA while on hormone therapy. See what you think – and see my Clinical Trial Pointers below. Remember – you can pull out of a clinical trial whenever you want.
TIPS for PATIENTS – CLINICAL TRIALS:
Think of a clinical trial as another treatment choice. Therefore, weigh the Risks and Benefits with your doctors and nurses, just like any other treatment.
Here are some things to consider & discuss:
- How long is the enrollment process for this trial? (it’s usually 3-4 weeks) How does that affect your current cancer situation? What is your PSA Doubling Time (PSADT), for example? (you can calculate PSADT here)
- Can you do anything (as a patient or caregiver) to speed up that enrollment process? Ask to speak directly to the clinical trial nurse, who is usually a different nurse than your clinical visit nurse. Develop a relationship with them, and hand them any medical records they may not have.
- How much testing is involved? Is the patient willing to do that?
- Is there any travel or cost involved? Is the patient willing to do that?Remember, clinical trials are voluntary and you can pull out of a clinical trial any time you want.