Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Sharp HealthCare.
Recruitment status was  Recruiting
Sponsor:
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
  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 HealthCare:

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:
    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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 HealthCare
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 HealthCare:
Neoplasms
Urogenital neoplasm
Genital neoplasms, male

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014