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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00855647
Recruitment Status : Completed
First Posted : March 4, 2009
Last Update Posted : June 3, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Procedure: Hypo-fractionated Radiotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99999 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)
Study Start Date : August 2003
Actual Primary Completion Date : March 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. PSA response that achieves a stable nadir over time.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00855647

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Christopher R. King Stanford University

Responsible Party: Christopher R. King, Stanford University School of Medicine Identifier: NCT00855647     History of Changes
Other Study ID Numbers: SU-11022007-792
First Posted: March 4, 2009    Key Record Dates
Last Update Posted: June 3, 2010
Last Verified: June 2010

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