ProstVac for Newly Diagnosed or AS Patients? Check this out….

By Jan Manarite, VP of Advocacy & Education

This has to be one of the most interesting clinical trials I’ve seen for prostate cancer patients in a long time.  This trial is for men who have low risk or intermediate risk prostate cancer, and are on Active Surveillance (AS), or Newly Diagnosed, and have not had treatment yet. 

This trial offers the immunotherapy ProstVac to these patients, who would otherwise have no access to it at all.  Remember that most immunotherapy treatments have very few side effects.  One of the most common side effects with ProstVac, for example, is irritation at the injection site and short term nausea or fatigue. (Ref, Ref)  

Here are some of the benefits of this trial:

  • ProstVac is NOT FDA Approved yet, so it is unavailable anywhere, except in a clinical trial like this one.
  • If and when ProstVac receives FDA Approval, it will be for men who are advanced prostate cancer patients, not AS, or low risk.  So it will still be unavailable for these men, except in a clinical trial like this one.
  • There are VERY FEW clinical trials with immunotherapy for men on AS.  For me – I have never seen one before.
  • ProstVac is in the same class of drugs as PROVENGE, called immunotherapy.  It does not have a lot of side effects usually, but is intended to boost your own immune system.
  • There is placebo in this trial, but 2/3 of the patients receive ProstVac.  Only 1/3 receive placebo. 

Here is the Link, and Basic Eligibility Criteria for the clinical trial,
Prostvac (PSA-TRICOM) in Preventing Disease Progression in Patients With Localized Prostate Cancer Undergoing Active Surveillance
(Currently in Baltimore, San Diego, and Irvine.  Other sites pending – check link above.)

Basic Eligibility Criteria:

  • PSA less than 15.0
  • Gleason 3+4=7, or less
  • DRE (Clinical Stage) T1c or T2a
  • At least 10 cores taken on biopsy
  • No more than 50% of the (random) cores are cancerous
  • No previous prostate cancer treatments

Check Contacts and Locations Here

 As always, research first, then discuss with your physicians and nurses.




Do All Clinical Trials Have Placebo?


By Jan Manarite, VP of Education and Advocacy

The answer is ‘no’ – not all clinical trials have a placebo. 

Most Phase 1 and 2 trials DO NOT have a placebo, but most Phase 3 trials DO have a placebo group (arm).  That being said, it is probably the first question you should ask if you are considering a clinical trial.  ASK – don’t turn down a trial until you know the facts.

In addition, most placebo trials (usually the Phase 3) are now designed so that only 1/3 of patients receive placebo, therefore 2/3 of the patients receive the trial drug.  Again, ASK – because all clinical trials are designed differently.

Most placebo trials are now designed so that 1/3 of patients receive placebo,  but 2/3 receive the trial drug.  ASK – because all clinical trials are different.

Finally, some clinical trials that have a placebo group, have a “crossover provision” written into the trial.  This means that if a patient on placebo has disease progression, he is offered the option to “crossover” into the group that receives the trial drug or sometimes offered another drug. 

One example of this is the Phase 3 trials years ago for PROVENGE (sipuleucel-T).  In some of the trials, patients who received placebo were eventually offered PROVENGE if their prostate cancer progressed.

Another example is the current Phase 3 SPARTAN trial which has a crossover provision.  The trial is for prostate cancer patients who have a rising PSA on hormone therapy, but no metastases.  In this case, men who are on placebo, but have cancer progression are not offered the trial drug (ARN509), but they are offered free Zytiga (abiraterone).

So if you are considering a clinical trial, remember that they are all different.  Develop some questions for the trial nurse or your physician based on your priorities and concerns.  Simply put – ASK.  And remember that most Phase 1 or Phase 2 clinical trials don’t have a placebo.  If you are considering a Phase 3 trial, ask what percentage of patients receive placebo and ask if there is a crossover provision if you progress on placebo.

Better questions will get you better answers.  Keep researching, and keep asking.




PSA Rising on Hormone Therapy? Here are 2 Interesting Clinical Trials – Take a Look!

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.

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ODM-201 in Men with High-risk Non-Metastatic Castration-resistant
Prostate Cancer (ARAMIS)

(ODM-201 is a 2nd line hormonal therapy given as pills)
Phase 3 Study – – 2/3 receive drug, 1/3 receive placebo

Basic Eligibility Criteria: 
(check trial site for full criteria)

  • Castration-resistant PC (PSA rising on hormone therapy)
  • No Metastasis
  • No previous PROVENGE or chemo
  • No previous Proscar or Avodart
  • No previous ketoconazole, Nilandron, Zytiga, or Xtandi

Locations: 25 different states

Click here to see if you qualify.   

 

ARN-509in Men with Non-metastatic Castration-resistant Prostate Cancer (SPARTAN)
(ARN-509 is a 2nd line hormonal therapy given as pills)
Phase 3 Study – – 2/3 receive drug, 1/3 receive placebo.  BUT – patients who progress on placebo will be offered free abiraterone (Zytiga).


Basic Eligibility Criteria:
 (check trial site for full criteria)

  • Castration-resistant PC (PSA rising on hormone therapy)
  • 3 PSA rises, at least one week apart
  • No Metastasis
  • At least 4 weeks since Casodex, Nilandron, or estrogens
  • At least four weeks since Proscar or Avodart
  • No previous ketoconazole or Zytiga

Locations32 different states

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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.