Leuprolide, Bicalutamide, and Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer After External-Beam Radiation Therapy

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide and bicalutamide, may lessen the amount of androgens made by the body. Implant radiation therapy kills tumor cells by placing material such as radioactive iodine directly into or near a tumor. Giving leuprolide and bicalutamide together with implant radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving leuprolide and bicalutamide together with implant radiation therapy and to see how well it works in treating patients with locally recurrent prostate cancer after external-beam radiation therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bicalutamide; Leuprolide

Criteria

DISEASE CHARACTERISTICS:

• Biopsy-proven adenocarcinoma of the prostate

• Locally recurrent disease, defined by digital rectal examination and/or rising prostate-specific antigen (PSA)

• No evidence of nodal or distant metastasis (i.e., N0, M0) on physical examination, bone scan, or CT scan of the pelvis

• Clinical stage T1c-T3a disease at the time of recurrence

• PSA < 10 ng/mL

• Prostate volume by transrectal ultrasonography < 60 cc

• Received prior external beam radiotherapy

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• WBC ≥ 3,000/μL

• Platelet count ≥ 90,000/μL

• Hemoglobin ≥ 10 g/dL

• Alkaline phosphatase < 2 times normal

• AST < 2 times normal

• Normal prothrombin time and partial thromboplastin time

• No significant obstructive urinary symptoms (AUA score ≤ 16)

• No contraindication for general anesthesia

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior transurethral resection of the prostate