RATIONALE: Applying topical amifostine to the rectum before undergoing radiation therapy may protect healthy tissue and decrease the side effects of radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of topical amifostine in protecting the rectum in patients who are undergoing radiation therapy for prostate cancer.

OBJECTIVES:

• Determine acute rectal toxicity in patients with prostate cancer receiving topical amifostine and radiotherapy.
• Determine late rectal toxicity in patients treated with this regimen.
• Determine the relationship between this regimen and toxicity, quality of life, rectal dose-volume histograms, and proctoscopic examinations in these patients.

OUTLINE: Patients are stratified according to prior prostatectomy (yes vs no) and risk (low vs intermediate vs high).

Patients receive amifostine intrarectally over 30-90 seconds 30-45 minutes prior to radiotherapy 5 days a week for 7-8 weeks. Patients are advised to retain the amifostine for as long as possible (at least 20 minutes) until the radiation treatment has been delivered. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at weeks 5 and 7 during therapy, at 1 month, every 3 months for 6 months, every 6 months for 1.5 years, and then annually for 3 years.

Patients are followed at 1 month, every 3 months for 6 months, every 6 months for 1.5 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study within 1 year.

• Prostate Cancer
• Radiation Toxicity

• Drug: amifostine trihydrate
• Radiation: radiation therapy

• Simone NL, Menard C, Soule BP, Albert PS, Guion P, Smith S, Godette D, Crouse NS, Sciuto LC, Cooley-Zgela T, Camphausen K, Coleman CN, Singh AK. Intrarectal Amifostine During External Beam Radiation Therapy for Prostate Cancer Produces Significant Improvements in Quality of Life Measured by EPIC Score. Int J Radiat Oncol Biol Phys. 2007 Sep 11; [Epub ahead of print]
• Muanza TM, Albert PS, Smith S, Godette D, Crouse NS, Cooley-Zgela T, Sciuto L, Camphausen K, Coleman CN, Ménard C. Comparing measures of acute bowel toxicity in patients with prostate cancer treated with external beam radiation therapy. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1316-21.
• Menard C, Camphausen K, Muanza T, Sears-Crouse N, Smith S, Ben-Josef E, Coleman CN. Clinical trial of endorectal amifostine for radioprotection in patients with prostate cancer: rationale and early results. Semin Oncol. 2003 Dec;30(6 Suppl 18):63-7.

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• No distant metastatic disease

  • Negative bone scan necessary if prostate-specific antigen (PSA) is greater than 10 ng/mL or Gleason score is greater than 7

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• No other active malignancy except nonmelanoma skin cancer
• No chronic inflammatory bowel disease
• No cognitive impairment that would preclude informed consent
• No other medical condition that would preclude study participation
• HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Concurrent PSA vaccine allowed provided patient is also enrolled on protocol NCI-00-C-0154

Chemotherapy

• No concurrent cytotoxic chemotherapy

Endocrine therapy

• Concurrent anti-androgen therapy allowed for intermediate- or high-risk patients

Radiotherapy

• No prior pelvic or prostatic radiotherapy

Surgery

• Not specified