Trial record 12 of 21 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 August 01, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male