Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Radiation: radiation therapy
- Registration Number
- NCT00062309
- Lead Sponsor
- Fox Chase Cancer Center
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays and other sources of radiation to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with stage II or stage III prostate cancer.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 307
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CIMRT radiation therapy 76 Gy in 38 fractions HIMRT radiation therapy 70.2 Gy in 26 fractions
- Primary Outcome Measures
Name Time Method Freedom from biochemical and/or disease failure rates weekly during treatment, at 3 months, 6 months or 2 years then yearly
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States