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Clinical Trials/NCT00855647
NCT00855647
Completed
Phase 2

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

Stanford University1 site in 1 country99,999 target enrollmentAugust 2003

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Prostatic Neoplasms
Sponsor
Stanford University
Enrollment
99999
Locations
1
Primary Endpoint
PSA response that achieves a stable nadir over time.
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2003
End Date
July 2009
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Eligibility 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).

Outcomes

Primary Outcomes

PSA response that achieves a stable nadir over time.

Study Sites (1)

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