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| Descriptive Information Fields | |||||||||
| Brief Title † | Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer | ||||||||
| Official Title † | Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer | ||||||||
| Brief Summary | RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This trial is studying the side effects of stereotactic radiation therapy and to see how well it works in treating patients with prostate cancer. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Patients are stratified according to risk group (low risk vs low/intermediate risk). Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days. Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms). After completion of study therapy, patients are followed for up to 5 years. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment | ||||||||
| Primary Outcome Measure † | Rate of acute toxicities as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ] | ||||||||
| Secondary Outcome Measure † | Rate of late grade 3-5 toxicities as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ] Biochemical disease-free survival [ Designated as safety issue: No ] Disease-free survival (Phoenix and ASTRO definitions) [ Designated as safety issue: No ] Disease-specific survival [ Designated as safety issue: No ] Overall survival [ Designated as safety issue: No ] Rate of local failure [ Designated as safety issue: No ] Rate of distant failure [ Designated as safety issue: No ] Quality of life as measured by the Short Form-12 Health Survey, Expanded Prostate Cancer Index Composite, and the American Urological Association Symptom Index, and the Utilization of Sexual Medications/Devices [ Designated as safety issue: No ] |
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| Condition † | Prostate Cancer | ||||||||
| Intervention † | Procedure: quality-of-life assessment Procedure: questionnaire administration Procedure: stereotactic radiosurgery |
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| MEDLINE PMIDs | |||||||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 102 | ||||||||
| Start Date † | December 2007 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Male | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00619515 | ||||||||
| Organization ID | CDR0000583273 | ||||||||
| Secondary IDs †† | CASE-13807 | ||||||||
| Study Sponsor † | Case Comprehensive Cancer Center | ||||||||
| Collaborators †† | National Cancer Institute (NCI) | ||||||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | May 2008 | ||||||||
| First Received Date † | February 20, 2008 | ||||||||
| Last Updated Date | July 23, 2008 | ||||||||