Back to resultsStereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
Primary Purpose
Prostatic Neoplasm
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasm focused on measuring Neoplasms, Urogenital neoplasm, Genital neoplasms, male
Eligibility 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 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.
Sites / Locations
- Sharp Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SBRT
Arm Description
Stereotactic Body Radiation Therapy
Outcomes
Primary Outcome Measures
acute and late toxicity to the GU and GI systems
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)
One year biochemical control rate of >90%.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01540994
Brief Title
Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
Official Title
Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
April 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sharp HealthCare
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm
Keywords
Neoplasms, Urogenital neoplasm, Genital neoplasms, male
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Radiotherapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SBRT
Arm Type
Experimental
Arm Description
Stereotactic Body Radiation Therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
Stereotactic Body Radiation Therapy
Primary Outcome Measure Information:
Title
acute and late toxicity to the GU and GI systems
Description
acute and late toxicity to the GU and GI systems based on the RTOG definitions will be compared to those of standard radiation therapy.
Time Frame
1 year follow-up
Secondary Outcome Measure Information:
Title
Drop in the PSA (biochemical marker)
Description
One year biochemical control rate of >90%.
Time Frame
1 year follow-up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey Weinstein, M.D.
Organizational Affiliation
Sharp HealthCare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
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