At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of prostate cancer
- ✓Castrate-resistant disease with rising PSA despite continuous androgen deprivation therapy (orchiectomy or LHRH agonist)
- ✓Rising PSA after anti-androgen withdrawal
- ✓Serum testosterone <50 ng/mL
- ✕Any evidence of metastatic disease on bone or CT scan
- ✕Evidence of immunosuppression or current immunosuppressive agent therapy
- ✕LHRH agonist discontinued less than 6 months prior to study entry (if not previously treated by orchiectomy)
- ✕Concurrent use of medications or supplements with known hormonal effects other than LHRH agonist
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Randomized Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating pTVG-HP with rhGM-CSF for Prostate Cancer. Completed, enrolled 17 participants across 1 site.
Detailed Summary
The investigators are trying to find new methods to treat prostate cancer. The approach is to try to enhance patients' own immune response against the cancer. In this study, the investigators will be testing the safety of a vaccine that may be able to help the body fight prostate cancer. The vaccine, called pTVG-HP, is a piece of DNA genetic material that contains genetic code for a protein that is made by the prostate gland, called prostatic acid phosphatase (PAP). The vaccine will be given together with a substance called an adjuvant. Adjuvants are typically given with vaccines and can improve the effect of the vaccine. The adjuvant that will be used in this study is called granulocyte-macrophage colony-stimulating factor (GM-CSF). The main purpose of this study is to find out whether the vaccine generates long-lived immune responses, and whether a better schedule of vaccination can be found by doing frequent laboratory testing for immune responses. The investigators also want to see if the vaccine stimulates any immune reaction against cancer cells.
Study Details
Timeline
Interventions
pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression
pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response.