- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01540994
Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
September 23, 2019 updated by: Geoffrey Weinstein, M.D., Sharp HealthCare
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92123
- Sharp Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SBRT
Stereotactic Body Radiation Therapy
|
Stereotactic Body Radiation Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drop in the PSA (biochemical marker)
Time Frame: 1 year follow-up
|
One year biochemical control rate of >90%.
|
1 year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Geoffrey Weinstein, M.D., Sharp HealthCare
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
April 5, 2019
Study Completion (Actual)
April 5, 2019
Study Registration Dates
First Submitted
February 23, 2012
First Submitted That Met QC Criteria
February 28, 2012
First Posted (Estimate)
February 29, 2012
Study Record Updates
Last Update Posted (Actual)
September 25, 2019
Last Update Submitted That Met QC Criteria
September 23, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101091
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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