A Phase II Open Label Trial of Amifostine Plus Fractionated Radiotherapy for Primary Prostate Adenocarcinoma (T1a-T3b, NoMo, PSA>10 ng/ml) to Estimate Acute Grade 2 Genitourinary and Gastrointestinal Toxicity
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.
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.
Primary Purpose: Treatment
James R. Oleson, MD, PhD
University of Arizona
United States: Federal Government
|Arizona Cancer Center||Tucson, Arizona 85724|