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| Descriptive Information Fields | |||||||||
| Brief Title † | High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy | ||||||||
| Official Title † | Pilot Study of High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy | ||||||||
| Brief Summary | High dose rate (HDR) brachytherapy is a form of radiation treatment using temporary radioactive seeds. This is done by placing very tiny catheters or tubes into the prostate and then inserting temporary radioactive seeds, called Iridium 192, through these catheters. HDR brachytherapy gives precise radiation to the prostate with less radiation given to the normal tissues near the prostate. For patients who have been treated with external beam radiation to the prostate before, HDR brachytherapy can give radiation again to the prostate without exposing the normal tissues around the prostate to significantly more radiation. This may be safer than giving external beam radiation again. The purpose of this study is to test the safety of high dose rate temporary brachytherapy (HDR) for prostate cancer that has come back after external beam radiation. We want to find out what effects, good and/or bad, the treatment has on you and your recurrent prostate cancer. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | assess feasibility & toxicity of HDR as salvage ther for local recurrent prostate cancer after ext beam radiotherapy. QOL instruments and questionnaires including the MSK prostate QOL instrument, the IIEF, IPSS , & the NCI CTC is used to assess toxicity. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ] | ||||||||
| Secondary Outcome Measure † | To assess biochemical or PSA relapse free survival. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Prostate Cancer | ||||||||
| Intervention † | Radiation: High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | Memorial Sloan-Kettering Cancer Center  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 40 | ||||||||
| Start Date † | September 2006 | ||||||||
| Completion Date | September 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00604526 | ||||||||
| Organization ID | 06-122 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Memorial Sloan-Kettering Cancer Center | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||||||
| Verification Date | July 2008 | ||||||||
| First Received Date † | January 8, 2008 | ||||||||
| Last Updated Date | July 21, 2008 | ||||||||
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