Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)
Phase 2
Completed
- Conditions
- Prostatic Neoplasms
- Registration Number
- NCT00855647
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 99999
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.
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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).
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method PSA response that achieves a stable nadir over time.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Stanford University School of Medicine
🇺🇸Stanford, California, United States