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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
  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
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:


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
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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on June 26, 2017