Back to resultsHypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)
Primary Purpose
Prostatic Neoplasms
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hypo-fractionated Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms
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).
Sites / Locations
- Stanford University School of Medicine
Outcomes
Primary Outcome Measures
PSA response that achieves a stable nadir over time.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00855647
Brief Title
Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)
Official Title
Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
99999 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Hypo-fractionated Radiotherapy
Primary Outcome Measure Information:
Title
PSA response that achieves a stable nadir over time.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher R. King
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)
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