Prostvac in Patients With Biochemically Recurrent Prostate Cancer

BACKGROUND * Androgen deprivation therapy (ADT) and surveillance are treatment options for prostate cancer patients with biochemical progression after localized therapy (biochemically recurrent prostate cancer). The primary goal in these patients is to prevent morbidity from their cancer and to do so with limited toxicity. * Prostvac (Prostvac; developed by the National Cancer Institute \[NCI\] and licensed to BN Immunotherapeutics, Mountain View, CA) is a novel candidate prostate cancer immunotherapy for the treatment of prostate cancer. It is a viral vector based therapeutic cancer vaccine that is administered via subcutaneous injections. In a randomized controlled Phase 2 trial, Prostvac therapy was associated with a prolongation of survival in men with metastatic castrate-resistant prostate cancer. A phase III trial recently completed accrual of patients in this same population. * There is also rationale to use therapeutic cancer vaccines such as Prostvac in earlier stage prostate cancer patients to maximize the potential therapeutic effect of immune stimulating therapy. * Analysis of previous trials using therapeutic cancer vaccines alone suggests that such therapies may alter tumor growth rate. OBJECTIVE Primary Objective: -Determine if the therapeutic cancer vaccine prostvac can decrease tumor growth rate as measured by prostate-specific antigen (PSA) rise after 6 months compared to a group getting surveillance alone. KEY ELIGIBILITY CRITERIA * Histologically confirmed adenocarcinoma of the prostate * Patients with negative computed tomography (CT) Scan and Tc-99m Bone Scan * Patients with a PSA over 0.8 ng/ml for patients following radical prostatectomy or for patients following definitive radiation therapy: a rise in PSA of greater than or equal to 2 ng/mL above the nadir * Patients with a PSA doubling time of 5-15 months * No history of active autoimmune disease or history of organ compromising autoimmune disease * Eastern Cooperative Oncology Group (ECOG) 0 -1 DESIGN * Randomized study * Accrual goal is 36 evaluable patients per arm; randomized 1:1 to: * Arm A: Prostvac for 6 months with an additional optional year of maintenance for eligible patients OR * Arm B: Surveillance for 6 months, then Prostvac for 6 months with an additional year of maintenance for eligible patients