Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01540994
Recruitment Status : Recruiting
First Posted : February 29, 2012
Last Update Posted : May 1, 2017
Information provided by (Responsible Party):
Geoffrey Weinstein, M.D., Sharp HealthCare

February 23, 2012
February 29, 2012
May 1, 2017
January 2011
June 2019   (Final data collection date for primary outcome measure)
acute and late toxicity to the GU and GI systems [ Time Frame: 1 year follow-up ]
acute and late toxicity to the GU and GI systems based on the RTOG definitions will be compared to those of standard radiation therapy.
Same as current
Complete list of historical versions of study NCT01540994 on Archive Site
Drop in the PSA (biochemical marker) [ Time Frame: 1 year follow-up ]
One year biochemical control rate of >90%.
Same as current
Not Provided
Not Provided
Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate
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.
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.
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostatic Neoplasm
Radiation: radiation therapy
Stereotactic Body Radiation Therapy
Experimental: SBRT
Stereotactic Body Radiation Therapy
Intervention: Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2019
June 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male with any age (typically 50 to 70 years old) with a low risk disease. This is defined as a Gleason's score of 6 or less, clinical stage of T2a or less, and a PSA of less than 15. We will also include patients with Gleason's score of 3+4=7 if there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate dimension.

Exclusion Criteria:

  • Prior surgery or radiotherapy for prostate cancer, PSA over 10, Gleason scores 7, 8, 9, or 10 (except Gleason 7 as noted, above), or clinical stage T2b, T2c, T3, or T4.
Sexes Eligible for Study: Male
50 Years to 90 Years   (Adult, Senior)
Contact: Geoffrey Weinstein, M.D. 858-939-5010
United States
Not Provided
Not Provided
Geoffrey Weinstein, M.D., Sharp HealthCare
Sharp HealthCare
Not Provided
Principal Investigator: Geoffrey Weinstein, M.D. Sharp HealthCare
Sharp HealthCare
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP