Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
This study is currently recruiting participants.
Verified March 2012 by Sharp Memorial Hospital
Sponsor:
Sharp Memorial Hospital
Information provided by (Responsible Party):
Geoffrey Weinstein, M.D., Sharp Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01540994
First received: February 23, 2012
Last updated: March 9, 2012
Last verified: March 2012
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Purpose
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 Memorial Hospital:
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 Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Radiation: radiation therapy
Stereotactic Body 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.
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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 10. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540994
Contacts
| Contact: Geoffrey Weinstein, M.D. | 858-939-5010 | Geoffrey.Weinstein@sharp.com |
Locations
| 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. | |
Sponsors and Collaborators
Sharp Memorial Hospital
Investigators
| Principal Investigator: | Geoffrey Weinstein, M.D. | Sharp HealthCare |
More Information
No publications provided
| Responsible Party: | Geoffrey Weinstein, M.D., Medical Director, Radiation Oncology, Sharp Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01540994 History of Changes |
| Other Study ID Numbers: | 101091 |
| Study First Received: | February 23, 2012 |
| Last Updated: | March 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sharp Memorial Hospital:
|
Neoplasms Urogenital neoplasm Genital neoplasms, male |
Additional relevant MeSH terms:
|
Neoplasms Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013