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

This study is ongoing, but not recruiting participants.

First Received: March 2, 2009 Last Updated: July 7, 2009 History of Changes

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00855647

Purpose

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.

Condition	Intervention	Phase
Prostatic Neoplasms	Procedure: Hypo-fractionated Radiotherapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

PSA response that achieves a stable nadir over time.

Estimated Enrollment:	99999
Study Start Date:	August 2003
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855647

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Christopher R. King

Stanford University

More Information

No publications provided

Responsible Party:	Stanford University School of Medicine ( Christopher R. King, Principal Investigator )
Study ID Numbers:	SU-11022007-792, 79432, NCT00855647, PROS0020
Study First Received:	March 2, 2009
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00855647 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009