Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Sharp HealthCare
Information provided by (Responsible Party):
Geoffrey Weinstein, M.D., Sharp HealthCare Identifier:
First received: February 23, 2012
Last updated: April 18, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Prostatic Neoplasm
Radiation: radiation therapy
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Sharp HealthCare:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Drop in the PSA (biochemical marker) [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
    One year biochemical control rate of >90%.

Estimated Enrollment: 10
Study Start Date: January 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SBRT
Stereotactic Body Radiation Therapy
Radiation: radiation therapy
Stereotactic Body Radiation Therapy

Detailed Description:
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.

Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01540994

Contact: Geoffrey Weinstein, M.D. 858-939-5010

United States, California
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Geoffrey Weinstein, M.D.    858-939-5010   
Principal Investigator: Geoffrey Weinstein, M.D.         
Sponsors and Collaborators
Sharp HealthCare
Principal Investigator: Geoffrey Weinstein, M.D. Sharp HealthCare
  More Information

Responsible Party: Geoffrey Weinstein, M.D., Medical Director, Radiation Oncology, Sharp HealthCare Identifier: NCT01540994     History of Changes
Other Study ID Numbers: 101091 
Study First Received: February 23, 2012
Last Updated: April 18, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Sharp HealthCare:
Urogenital neoplasm
Genital neoplasms, male

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on October 27, 2016