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.

Condition	Treatment or Intervention	Phase
stage II prostate cancer stage III prostate cancer stage I prostate cancer adenocarcinoma of the prostate radiation toxicity	Drug: amifostine	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the incidence, grade, and time course of acute grade 2 or higher gastrointestinal and genitourinary toxicities in patients with primary prostate adenocarcinoma receiving amifostine plus fractionated radiotherapy. II. Determine the incidence and nature of toxicity associated with amifostine in these patients. III. Assess tumor response to this treatment in these patients. IV. Assess impotency rates following radiotherapy in these patients.

PROTOCOL OUTLINE: This is an open label study. Patients receive fractionated radiotherapy five days per week for 7 weeks plus amifostine IV push over 5 minutes, 15 minutes before each radiation treatment. Patients are followed at 1 month after radiotherapy, and then every 3 months for at least 5 years.

PROJECTED ACCRUAL: There will be 25 patients accrued into this study over 2 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States

Study chairs or principal investigators

James R. Oleson,  Study Chair,  Arizona Cancer Center   

Study ID Numbers:  CDR0000066254; UARIZ-HSC-9817; NCI-V98-1412; ALZA-98-005-ii
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003307
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08