This phase II trial aims to evaluate the effectiveness of a personalized peptide-based vaccine (Multi-Epitope TARP) on preventing progression of localized prostate cancer. The main outcome to be investigated is disease progression based on blood tests. The trial is recruiting in Maryland (USA).
The details
Immunotherapy has recently been under intense investigation as a possible treatment for prostate cancer. Immunotherapies, such as peptide-based vaccines, boost the patient’s own immune system to recognize and destroy cancer cells.
This study will examine the effectiveness of a peptide-based vaccine in reducing progression of localized prostate cancer. Men who continue to have elevated PSA levels (prostate-specific antigen, a protein present in prostate cancer) after their primary prostate cancer treatment are at increased risk of cancer recurrence. This study will measure disease progression based on the change in PSA levels over time (also called PSA doubling time).
Who are they looking for?
This study will recruit about 75 men with recurrent cancer confined to the prostate gland, who have completed and recovered from all primary prostate cancer treatments (including prostate surgery, radiation therapy, or cryotherapy). Hormone therapy must be completed at least 6 months prior to taking part. Patients must present with elevated or rising PSA levels (a PSA doubling time between 3 and 15 months). Full blood counts will also be evaluated before taking part. Participants should have a life expectancy of at least 1 year.
Participants cannot take part in the trial if the cancer has spread outside the prostate. Previous immunotherapy or alternative therapies known to alter PSA levels are not permitted. Patients should not be receiving medication for urinary symptoms. Testosterone levels should not be very low. Patients should not have hepatitis, HIV, an active infection, any other active cancers (with the exception of treated skin cancer), or present with any significant or uncontrolled medical illness.
How will it work
Participants will be screened with blood tests, scans, a physical exam, and medical history. The peptide-based vaccine will be made from the participants own cells. This involves taking a blood sample from one arm. A machine will separate the white blood cells. The blood, minus the white cells, will be returned through a needle in the other arm.
An initial group of 6 participants will be enrolled to examine the safety of the peptide-based vaccine over the course of 12 weeks. The rest of the participants will then be randomly allocated to undergo treatment with a peptide-based vaccine or placebo (a control substance with no effect on the body). The peptide-based vaccine will be administered via injection under the skin a total of 6 times at Weeks 3, 6, 9, 12, 15, and 24.
Participants will have 14 visits. At each visit, they will have a physical exam and blood tests, as well as the opportunity to discuss side effects. Blood tests will measure PSA levels to determine disease progression. The study will last 2 years.
