Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00855647
First received: March 2, 2009
Last updated: June 1, 2010
Last verified: June 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • PSA response that achieves a stable nadir over time. [ Time Frame: unknown ] [ Designated as safety issue: No ]

Estimated Enrollment: 99999
Study Start Date: August 2003
Study Completion Date: July 2009
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: Christopher R. King, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00855647     History of Changes
Other Study ID Numbers: SU-11022007-792, 79432, PROS0020
Study First Received: March 2, 2009
Last Updated: June 1, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 26, 2012