Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
The purpose of this study is to evaluate a short course (five radiation treatments) of very focused ("stereotactic") external beam radiation therapy for the treatment of early stage prostate cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate|
- acute and late toxicity to the GU and GI systems [ Time Frame: 1 year follow-up ] [ Designated as safety issue: Yes ]acute and late toxicity to the GU and GI systems based on the RTOG definitions will be compared to those of standard radiation therapy.
- Drop in the PSA (biochemical marker) [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]One year biochemical control rate of >90%.
|Study Start Date:||January 2011|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Radiation: radiation therapy
External beam radiation therapy for prostate cancer, while effective, takes up to 9 weeks to deliver on a Monday through Friday basis. Recent phase I/II studies from Seattle and Palo Alto using stereotactic guidance to deliver high doses of radiation to the prostate over a 1 to 2 week period of time suggest that outcomes may be equal or superior to standard approaches. These data, combined with markedly improved convenience for patients, make radiosurgery (SBRT) for early-stage prostate cancer an enticing option. The goal of this study is to offer a radiosurgical option to patients within the Sharp system under the umbrella of an IRB-approved study.
|Contact: Geoffrey Weinstein, M.D.||858-939-5010||Geoffrey.Weinstein@sharp.com|
|United States, California|
|Sharp Memorial Hospital||Recruiting|
|San Diego, California, United States, 92123|
|Contact: Geoffrey Weinstein, M.D. 858-939-5010 Geoffrey.Weinstein@sharp.com|
|Principal Investigator: Geoffrey Weinstein, M.D.|
|Principal Investigator:||Geoffrey Weinstein, M.D.||Sharp HealthCare|