Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

This study is currently recruiting participants.

See

Contacts and Locations

Verified April 2017 by Geoffrey Weinstein, M.D., Sharp HealthCare

Sponsor:

Information provided by (Responsible Party):

Geoffrey Weinstein, M.D., Sharp HealthCare

ClinicalTrials.gov Identifier:

NCT01540994

First received: February 23, 2012

Last updated: April 27, 2017

Last verified: April 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

February 23, 2012

Last Updated Date

April 27, 2017

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01540994 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Drop in the PSA (biochemical marker) [ Time Frame: 1 year follow-up ]

One year biochemical control rate of >90%.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

Official Title ^ICMJE

Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment

Condition ^ICMJE

Prostatic Neoplasm

Intervention ^ICMJE

Radiation: radiation therapy

Stereotactic Body Radiation Therapy

Study Arms

Experimental: SBRT

Stereotactic Body Radiation Therapy

Intervention: Radiation: radiation therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2019

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

Male

Ages

50 Years to 90 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Geoffrey Weinstein, M.D.

858-939-5010

Geoffrey.Weinstein@sharp.com

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01540994

Other Study ID Numbers ^ICMJE

101091

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Geoffrey Weinstein, M.D., Sharp HealthCare

Study Sponsor ^ICMJE

Sharp HealthCare

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Geoffrey Weinstein, M.D.

Sharp HealthCare

PRS Account

Sharp HealthCare

Verification Date

April 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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