Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate recurrent prostate cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 23
Healthy volunteers: no

Brief summary:
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, leuprolide, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Giving bortezomib with hormone therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bortezomib with or without hormone therapy works in treating patients with relapsed prostate cancer.

Detailed description:

Arms:
arm 1: Patient will complete Part A (Velcade only). If the patient has a complete response, he will come off study. If the patient has progressive disease, he will start Part B (Velcade + antiandrogen). If the patient has a partial response or stable disease, he will start Part B after at least a 7-day break. arm 2: Patient will start Part B after completing Part A or may be enrolled to part B only.

Interventions: intervention 1: Velcade intervention 2: LH-RH Agonist intervention 3: Androgen Receptor Antagonists
Intervention descriptions: intervention 1: Part A: 1.3 mg/m2 administered on days 1, 4, 8 and 11 followed by 10 days rest. A second cycle will be given at the same schedule. Cycle 3 will include 3 weekly injections.

Part B: 1.3mg/m2 administered weekly for 3 weeks followed by 1 week break intervention 2: given as a 3 month depo-injection intervention 3: given orally daily for 3 months

Protocol document: