Trial record 12 of 20 for:
cyberknife, prostate cancer
Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)
This study has been completed.
Information provided by:
First received: March 2, 2009
Last updated: June 1, 2010
Last verified: June 2010
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.
Procedure: Hypo-fractionated Radiotherapy
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)
Primary Outcome Measures:
- PSA response that achieves a stable nadir over time. [ Time Frame: unknown ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2009 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855647
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
||Christopher R. King
No publications provided
||Christopher R. King, Stanford University School of Medicine
History of Changes
|Other Study ID Numbers:
||SU-11022007-792, 79432, PROS0020
|Study First Received:
||March 2, 2009
||June 1, 2010
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male