Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)

Phase 2

Completed

• Conditions: Prostatic Neoplasms

• Registration Number: NCT00855647
• Lead Sponsor: Stanford University

Brief Summary

To demonstrate that a hypo-fractionated course of radiotherapy (ie. an accelerated radiotherapy course where fewer but larger doses of radiotherapy are given) is both safe and effective in the treatment of low-risk localized prostate cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2009-03
• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-03
• Study First Posted: 2009-03-04
• Study Completion: 2009-07
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-01
• Last Update Posted: 2010-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 99999

Inclusion Criteria

• Eligible patients will have clinical stage T1c through T2b, initial PSA level <10 and a biopsy Gleason score of 3+3 or 3+4 with fewer than 50% of biopsy cores involved.

• Patients who have had any form of prior curative treatment (surgery, radiotherapy, cryotherapy) will not be eligible. A prior course of hormone therapy of less than 3 months duration will be allowed.
• Adult men will be considered.
• No life expectancy restrictions will apply.
• Performance Status will not be considered.
• No requirements for organ or marrow function will be made
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• No prior prostate treatment will be allowed.

• The use of other concurrent Investigational Agents will not be allowed.
• No exclusion requirements due to co-morbid disease or incurrent illness.
• No requirements regarding history of allergic reactions.
• Pregnancy or nursing patients is not applicable (ie. patients are male).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
PSA response that achieves a stable nadir over time.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States