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Prostatic Neoplasms

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Genital Diseases, Male

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Antineoplastic Agents

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Androgens

Hormones

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Leuprolide

Goserelin

Prolactin Release-Inhibiting Factors

Bicalutamide

Antineoplastic Agents, Hormonal

Androgen Antagonists

Hormone Antagonists

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.

Patients receive androgen ablation as in arm I. Patients 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.

GVAX prostate cancer vaccine

bicalutamide

goserelin

leuprolide acetate

Charles G. Drake, MD, PhD

Michael A. Carducci, MD

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy, such as bicalutamide, leuprolide, and goserelin, may lessen the amount of androgens made by the body. Vaccine therapy may help the body build an effective immune response to kill tumor cells. It is not yet known whether androgen ablation therapy is more effective with or without vaccine therapy in treating patients with prostate cancer.

PURPOSE: This randomized phase II trial is studying androgen ablation therapy to see how well it works when given together with or without vaccine therapy in treating patients with prostate cancer.

OBJECTIVES:

Primary

* 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.

Secondary

* 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 II) ratio.

* 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 annually thereafter.

Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer

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

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer	NCT00771017	Prostate Cancer	GVAX prostate c... bicalutamide goserelin leuprolide acet...	18 Years - 120 Years	Eastern Cooperative Oncology Group
Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer	NCT00771017	Prostate Cancer	GVAX prostate c... bicalutamide goserelin leuprolide acet...	18 Years - 120 Years	Eastern Cooperative Oncology Group

Spots Global Cancer Trial Database for gvax prostate cancer vaccine