NCT00855647
Completed
Phase 2
Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)
ConditionsProstatic Neoplasms
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.
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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