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| Tracking Information | |||||
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| First Received Date ICMJE | August 28, 2009 | ||||
| Last Updated Date | August 29, 2011 | ||||
| Start Date ICMJE | August 2009 | ||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
PSA decline measured through laboratory testing. [ Time Frame: One month following radiosurgery through 5 year follow up ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00969202 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Quality of life in relation to urinary, bowel and sexual function. Measured through a questionnaire at each follow up visit. [ Time Frame: One month following radiosurgery through 5 years follow up. ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer | ||||
| Official Title ICMJE | Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage | ||||
| Brief Summary | The purpose of this trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer. The investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating prostate cancer. |
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| Detailed Description | |||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase I | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE | Radiation: Stereotactic Radiosurgery using the Novalis Tx
Five treatments given every other day.
Other Names:
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| Study Arms | Experimental: Stereotactic Radiosurgery using NovalisTx
Single arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer.
Intervention: Radiation: Stereotactic Radiosurgery using the Novalis Tx |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 10 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00969202 | ||||
| Other Study ID Numbers ICMJE | SDRS0001 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | ( San Diego Radiosurgery ) | ||||
| Study Sponsor ICMJE | San Diego Radiosurgery | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | San Diego Radiosurgery | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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