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. |
ClinicalTrials.gov Identifier: NCT01540994 |
Recruitment Status
:
Recruiting
First Posted
: February 29, 2012
Last Update Posted
: May 1, 2017
|
Sponsor:
Sharp HealthCare
Information provided by (Responsible Party):
Geoffrey Weinstein, M.D., Sharp HealthCare
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 |
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 |
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 |
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:
Exclusion Criteria:
|
||||
Sex/Gender |
|
||||
Ages | 50 Years to 90 Years (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
|
||||
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 |
|
||||
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 |