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