Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue and may improve quality of life and help patients live more comfortably. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and bicalutamide may fight cancer by stopping the production of androgens. It is not yet known whether radiation therapy is more effective with or without goserelin and bicalutamide in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation therapy with or without bicalutamide and goserelin in treating patients who have prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Androgens; Bicalutamide; Goserelin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Unfavorable-risk disease, including at least 2 of the following characteristics:

• Prostate-specific antigen level greater than 10 ng/mL

• Gleason score greater than 7

• Stage T4

• Intermediate-risk disease with a Gleason score of at least 8 allowed

• Lymph nodes clinically negative by imaging studies or histologically negative by node sampling or lymph node dissection

• Prostate size less than 75 grams

• No distant metastases by bone scan, CT scan, or MRI

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 80-100%

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• SGOT and SGPT no greater than 1.5 times ULN

Renal

• Not specified

Other

• No documented history of inflammatory bowel disease

• No bilateral hip replacements

• No other invasive cancer except localized basal cell or squamous cell skin cancer unless disease free for at least 5 years

• No major medical or psychiatric illness that would preclude study completion, compliance, or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for prostate cancer

Endocrine therapy

• No prior androgen-deprivation therapy

Radiotherapy

• No prior pelvic radiotherapy

• No prior prostate brachytherapy

Surgery

• No prior bilateral orchiectomy

• No prior radical prostatectomy

• No prior cryotherapy for prostate cancer