A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation

Brief Summary

Detailed Description

OBJECTIVES: * Compare the efficacy of conventional intensity-modulated radiotherapy (IMRT) vs hypofractionated IMRT, in terms of freedom from biochemical failure in men with intermediate- to high-risk prostate cancer. * Compare the local control, freedom from distant metastasis, and overall survival of patients treated with these regimens. * Determine local failure, using biopsy of the prostate, when objective tests (prostate-specific antigen, ultrasound, and digital rectal exam) suggest relapse in these patients. * Compare the extent of disease eradication using biopsy of the prostate at 2 years after therapy in these patients. * Compare the quality of life of patients treated with these regimens. * Determine the impact of these regimens on patient preferences and utilities. OUTLINE: This is a randomized study. Patients are stratified according to pretreatment prostate-specific antigen (no greater than 10 ng/mL vs greater than 10 to 20 ng/mL vs greater than 20 ng/mL), Gleason score (5-7 vs 8-10), and risk status (high risk vs intermediate risk). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo conventional intensity-modulated radiotherapy (IMRT) 5 days a week for 7.5 weeks in the absence of disease progression or unacceptable toxicity. * Arm II: Patients undergo hypofractionated IMRT 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients with high-risk disease also undergo androgen deprivation therapy for 2 years. Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 4 years. Patients are followed at 3 months, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.

Primary Outcomes