Prostate Cancer Active Surveillance Metformin Trial
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ClinicalTrials.gov Identifier: NCT01733836 |
Recruitment Status
:
Withdrawn
(The reason for this decision is that this study is being merged with a larger multi-centre study using the same agent in the same population.)
First Posted
: November 27, 2012
Last Update Posted
: May 24, 2013
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Sponsor:
University Health Network, Toronto
Information provided by (Responsible Party):
University Health Network, Toronto
Tracking Information | |||
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First Submitted Date ICMJE | November 20, 2012 | ||
First Posted Date ICMJE | November 27, 2012 | ||
Last Update Posted Date | May 24, 2013 | ||
Study Start Date ICMJE | January 2013 | ||
Estimated Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | Complete list of historical versions of study NCT01733836 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 | Prostate Cancer Active Surveillance Metformin Trial | ||
Official Title ICMJE | A Randomized Double Blind Placebo Controlled Single Institution Phase 2 Study of Metformin in Patients Undergoing Active Surveillance for Prostate Cancer. | ||
Brief Summary | To determine whether the use of metformin in patients with low-risk prostate cancer can delay progression to clinically significant prostate cancer. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | ||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||
* 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 | Withdrawn | ||
Actual Enrollment ICMJE |
0 | ||
Original Estimated Enrollment ICMJE |
50 | ||
Estimated Study Completion Date | October 2014 | ||
Estimated Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Canada | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01733836 | ||
Other Study ID Numbers ICMJE | MAS_001 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | University Health Network, Toronto | ||
Study Sponsor ICMJE | University Health Network, Toronto | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | University Health Network, Toronto | ||
Verification Date | May 2013 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |