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Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

This study is currently recruiting participants.
Verified April 2017 by Geoffrey Weinstein, M.D., Sharp HealthCare
Sponsor:
ClinicalTrials.gov Identifier:
NCT01540994
First Posted: February 29, 2012
Last Update Posted: May 1, 2017
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.
Information provided by (Responsible Party):
Geoffrey Weinstein, M.D., Sharp HealthCare
  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: Intervention Model: Single Group Assignment
Masking: None (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 Geoffrey Weinstein, M.D., Sharp HealthCare:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Drop in the PSA (biochemical marker) [ Time Frame: 1 year follow-up ]
    One year biochemical control rate of >90%.


Estimated Enrollment: 10
Study Start Date: January 2011
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SBRT
Stereotactic Body Radiation Therapy
Radiation: radiation therapy
Stereotactic Body Radiation Therapy

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes 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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 HealthCare
Investigators
Principal Investigator: Geoffrey Weinstein, M.D. Sharp HealthCare
  More Information

Responsible Party: Geoffrey Weinstein, M.D., Medical Director, Radiation Oncology, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT01540994     History of Changes
Other Study ID Numbers: 101091
First Submitted: February 23, 2012
First Posted: February 29, 2012
Last Update Posted: May 1, 2017
Last Verified: April 2017

Keywords provided by Geoffrey Weinstein, M.D., Sharp HealthCare:
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


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