Radiation Therapy Plus Amifostine in Treating Patients With Primary Prostate Cancer

• Status: Completed
• Trial end date: 2001-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Amifostine may protect normal cells from the side effects of radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus amifostine in treating patients with primary prostate cancer.

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

Details

• Lead Sponsor: University of Arizona
• Collaborator: National Cancer Institute (NCI)
• Treatments: Amifostine

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed prostate adenocarcinoma Stage T1a-T3b N0 M0 disease PSA at least 10 ng/mL prior to treatment Must have a risk of seminal vesicle involvement between 10-25% No palpable or radiographic evidence of seminal vesicle involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 24 months Hematopoietic: Not specified Hepatic: SGOT and SGOT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No severe cerebrovascular disease or sustained hypotension not secondary to antihypotensive medication Other: No history of inflammatory bowel disease No history of malignancy other than nonmelanoma skin cancer No underlying medical or psychiatric illness that may impair ability to participate in study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the prostate area Surgery: No prior radical prostatectomy Other: No hypertensive medications if blood pressure less than 120/70