Status:

COMPLETED

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

Lead Sponsor:

Stanford University

Conditions:

Prostatic Neoplasms

Eligibility:

MALE

18+ years

Phase:

PHASE2

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 treatme...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

August 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2009

Estimated Enrollment :

99999 Patients enrolled

Trial Details

Trial ID

NCT00855647

Start Date

August 1 2003

End Date

July 1 2009

Last Update

June 3 2010

Active Locations (1)

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1

Stanford University School of Medicine

Stanford, California, United States, 94305