Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Massachusetts General Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Massachusetts General Hospital
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Metro West Medical Center
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00681694
First received: May 19, 2008
Last updated: April 27, 2010
Last verified: April 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 19, 2008 | ||||||||
| Last Updated Date | April 27, 2010 | ||||||||
| Start Date ICMJE | March 2002 | ||||||||
| Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To assess changes in generic and disease specific quality of life over time after treatment with brachytherapy for early prostate cancer [ Time Frame: 10 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00681694 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer | ||||||||
| Official Title ICMJE | Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer | ||||||||
| Brief Summary | The purpose of this research study is to assess outcomes of treatment for early prostate cancer. Current treatments for early (non-metastatic) cancer may cause long-term impairments in the patients quality of life. In this study we will compare the outcomes of patients treated with two alternative brachytherapy (seed implants) techniques using a series of questionnaires. |
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| Detailed Description | Participants will be asked to complete a questionnaire about their health prior to treatment, at 1, 3 and 12 months after treatment and then once a year 4 more times. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients who have indicated their intention to receive brachytherapy at one of the four accrual sites. |
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| Condition ICMJE | Prostate Cancer | ||||||||
| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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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 | 414 | ||||||||
| Estimated Completion Date | March 2011 | ||||||||
| Estimated Primary Completion Date | March 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 | NCT00681694 | ||||||||
| Other Study ID Numbers ICMJE | 01-264 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | James Talcott, MD, SM, Massachusetts General Hospital | ||||||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||||||
| Verification Date | April 2010 | ||||||||
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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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