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

June 1, 2010 updated by: Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

99999

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
PSA response that achieves a stable nadir over time.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Christopher R. King, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

March 2, 2009

First Submitted That Met QC Criteria

March 3, 2009

First Posted (Estimate)

March 4, 2009

Study Record Updates

Last Update Posted (Estimate)

June 3, 2010

Last Update Submitted That Met QC Criteria

June 1, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-11022007-792
  • 79432
  • NCT00855647
  • PROS0020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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