A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation
- 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
- 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
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.
Allocation: Randomized, Primary Purpose: Treatment
Freedom from biochemical and/or disease failure rates
Mark Buyyounouski, MD
Fox Chase Cancer Center
United States: Federal Government
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|