Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

Tracking Information
First Submitted Date ICMJE	February 23, 2012
First Posted Date ICMJE	February 29, 2012
Last Update Posted Date	May 1, 2017
Study Start Date ICMJE	January 2011
Estimated Primary Completion Date	June 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 28, 2012)	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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01540994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 28, 2012)	Drop in the PSA (biochemical marker) [ Time Frame: 1 year follow-up ]; One year biochemical control rate of >90%.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
Official Title ICMJE	Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate
Brief Summary	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.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Prostatic Neoplasm
Intervention ICMJE	Radiation: radiation therapy; Stereotactic Body Radiation Therapy
Study Arms	Experimental: SBRT; Stereotactic Body Radiation Therapy; Intervention: Radiation: radiation therapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: February 28, 2012)	10
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	June 2019
Estimated Primary Completion Date	June 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: Male
Ages	50 Years to 90 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Geoffrey Weinstein, M.D. 858-939-5010 Geoffrey.Weinstein@sharp.com
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01540994
Other Study ID Numbers ICMJE	101091
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Geoffrey Weinstein, M.D., Sharp HealthCare
Study Sponsor ICMJE	Sharp HealthCare
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Geoffrey Weinstein, M.D. Sharp HealthCare
PRS Account	Sharp HealthCare
Verification Date	April 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP