A Randomized, Phase II Trial of Brief Androgen-Ablation Combined With Cell-Based CG1940/CG8711 Immunotherapy For Prostate Cancer in Patients With Non-Metastatic, Biochemically Relapsed Prostate Cancer
- To determine the median PSA recurrence-free survival of patients with nonmetastatic,
biochemically relapsed prostate cancer who respond with a PSA ≤ 0.5 ng/mL when
administered a brief (6-month) course of androgen ablation either alone or in
combination with GVAX prostate cancer vaccine (CG1940/CG8711) immunotherapy.
- To determine the safety of combined treatment with androgen ablation and CG1940/CG8711
immunotherapy in these patients.
- To determine median time to metastatic disease development in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (>
7 vs ≤ 7), PSA doubling time (< 3 months vs 3-9 months vs > 9 months) and prior androgen
ablation (yes vs no). Patients are randomized to 1 of 2 treatment arms at a 1 (arm I):2 (arm
- Arm I (androgen-ablation therapy): Patients receive oral bicalutamide once daily on
days 1-28. Patients also receive luteinizing hormone-releasing hormone (LHRH) agonist
treatment comprising leuprolide acetate or goserelin intramuscularly (IM) on day 8.
Treatment with LHRH agonist repeats every 12 weeks for 24 weeks.
- Arm II (androgen-ablation therapy and vaccine): Patients receive androgen ablation as
in arm I. Patients also receive GVAX prostate cancer vaccine (CG1940 and CG8711)
intradermally (ID) on day 1. Beginning on day 1 of week 3, patients receive booster
doses of CG1940 and CG8711 ID every 2 weeks for 24 weeks.
Patients are evaluated on day 1 of week 25 to assess disease. If PSA > 0.5 ng/mL AND there
is no evidence of metastatic disease on imaging studies, then patients can be treated at the
discretion of the investigator. If PSA ≤ 0.5 ng/mL, and there is no evidence of metastatic
disease, then patients are considered responders and continue having PSA evaluated every 4
weeks until PSA relapse.
After completion of study therapy, patients are followed periodically for 5 years and then
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Median PSA recurrence-free survival in patients in patients responding to the study treatments
Charles G. Drake, MD, PhD
Sidney Kimmel Comprehensive Cancer Center