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| Descriptive Information Fields | |||||||||
| Brief Title † | Observation of Outcomes and Side Effects of Cesium-131 in Combination With External Beam Radiation for the Treatment of Intermediate to High Risk Prostate Cancer | ||||||||
| Official Title † | Dosimetric and Morbidity Outcomes of Cs-131 Brachytherapy in Combination With External Beam Radiation Therapy in Subjects With Intermediate to High Risk Adenocarcinoma of the Prostate: An Observational Study | ||||||||
| Brief Summary | The purpose of this study is to observe PSA response and incidence of side effects in patients diagnosed with intermediate to high risk prostate cancer and treated with Cesium-131 in combination of external beam therapy. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Cohort, Prospective | ||||||||
| Primary Outcome Measure † | The accumulation and analysis of dosimetric data resultant from Cs-131 permanent prostate brachytherapy in combination with external beam radiation therapy in the setting of intermediate to high risk cancer of the prostate. [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | The accumulation and analysis of treatment related morbidities and PSA control rates following Cs-131 prostate brachytherapy in combination with external beam therapy for intermediate to high risk cancer of the prostate. [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Prostate Cancer | ||||||||
| Intervention † | |||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Enrolling by invitation | ||||||||
| Enrollment † | 100 | ||||||||
| Start Date † | February 2007 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Intermediate Risk prostate cancer as determined by the following:
High risk prostate cancer as determined by the following:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00621413 | ||||||||
| Organization ID | isoray_cs131_pc01 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | IsoRay Medical, Inc. | ||||||||
| Collaborators †† | Swedish Medical Center | ||||||||
| Investigators † |
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| Information Provided By | IsoRay Medical, Inc. | ||||||||
| Verification Date | February 2008 | ||||||||
| First Received Date † | February 12, 2008 | ||||||||
| Last Updated Date | February 21, 2008 | ||||||||
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