Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer (SMART)
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ClinicalTrials.gov Identifier: NCT00941915 |
Recruitment Status :
Completed
First Posted : July 20, 2009
Results First Posted : January 24, 2022
Last Update Posted : January 24, 2022
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Sponsor:
Duke University
Information provided by (Responsible Party):
Duke University
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Tracking Information | |||||
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First Submitted Date ICMJE | July 17, 2009 | ||||
First Posted Date ICMJE | July 20, 2009 | ||||
Results First Submitted Date ICMJE | June 22, 2021 | ||||
Results First Posted Date ICMJE | January 24, 2022 | ||||
Last Update Posted Date | January 24, 2022 | ||||
Actual Study Start Date ICMJE | November 9, 2009 | ||||
Actual Primary Completion Date | February 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Toxicity [ Time Frame: 3 years ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer | ||||
Official Title ICMJE | A Phase II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Continuous Real-time Evaluation of Prostate Motion and IMRT Plan Reoptimization Based on the Anatomy of the Day | ||||
Brief Summary | The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period. The prostate is localized and the plan is reoptimized as needed prior to each treatment. | ||||
Detailed Description | This protocol requires radiation treatments to be performed with a stereotactic technique with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | ||||
Intervention ICMJE | Radiation: SBRT Prostate
Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
Other Names:
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Study Arms ICMJE | Experimental: Stereotactic Radiotherapy
Five fractions of 7.4 Gy each
Intervention: Radiation: SBRT Prostate
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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 | Completed | ||||
Actual Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | July 17, 2020 | ||||
Actual Primary Completion Date | February 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 82 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00941915 | ||||
Other Study ID Numbers ICMJE | Pro00018266 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Duke University | ||||
Original Responsible Party | Willliam Robert Lee, MD, Duke University Medical Center, Dept of Radiation Oncology | ||||
Current Study Sponsor ICMJE | Duke University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Duke University | ||||
Verification Date | November 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |