Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00946543
- Lead Sponsor
- Royal Marsden NHS Foundation Trust
- Brief Summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the best dose of intensity-modulated radiation therapy in treating patients with prostate cancer.
- Detailed Description
OBJECTIVES:
* To test the feasibility of delivering hypofractionated intensity-modulated radiotherapy to the prostate and pelvic nodes of patients with prostate cancer.
* To determine the optimal dose level of this treatment regimen to be used in future studies.
OUTLINE: Patients are stratified according to small bowel total volume (low small bowel volume \< 450 cc vs high small bowel volume ≥ 450 cc).
Patients undergo hypofractionated intensity-modulated radiotherapy to the prostate and pelvis for 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 5 years and then annually thereafter.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 198
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter
- Secondary Outcome Measures
Name Time Method Overall survival Local control PSA control Acute side effects as assessed weekly by the RTOG scoring system Quality of life Patterns of recurrence
Trial Locations
- Locations (3)
Institute of Cancer Research - Chelsea
🇬🇧London, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Institute of Cancer Research - Sutton
🇬🇧Sutton, England, United Kingdom