A Double-Blind Randomized Phase 2.5 Trial of ONY-P1 Vaccine Versus Placebo in Men With D0 Prostate Cancer Following Limited Androgen Ablation
- To determine whether ONY-P1 vaccine can increase the time to PSA-defined progression in
patients with androgen-dependent stage D0 prostate cancer.
- To evaluate all toxicities related to ONY-P1 vaccine.
- To compare the immunologic response in patients treated with ONY-P1 vaccine vs placebo.
- To evaluate PSA kinetics (doubling time/velocity) of treatment.
- To evaluate time to testosterone recovery following limited androgen ablation.
OUTLINE: Patients are stratified according to estimated PSA doubling time (< 12 months vs ≥
Patients receive goserelin subcutaneously once. Approximately 3 months later, patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive ONY-P1 vaccine with BCG intradermally on days 1 and 15.
Patients then receive ONY-P1 vaccine alone on day 29 and then every 4 weeks for up to
12 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive placebo vaccine intradermally on days 1, 15, and 29 and then
every 4 weeks for up to 12 months in the absence of disease progression or unacceptable
After completion of study therapy, patients are followed periodically for up to 15 years.
Allocation: Randomized, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Time to PSA progression
James L. Gulley, MD, PhD, FACP
National Cancer Institute (NCI)
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|