Metformin in Patients Initiating ADT as Prevention and Intervention of Metabolic Syndrome
NCT03031821 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168
Last updated 2024-10-04
Summary
This is a multi-centre, double-blind, randomized phase III trial comparing metformin to placebo in patients with advanced prostate cancer starting (or have recently started) androgen deprivation therapy (ADT).
Conditions
- Prostate Cancer
- Metabolic Syndrome
Interventions
- DRUG
-
Metformin Duration: 18 months 850 mg PO OD x 30 days then 850 mg PO BID for duration
- DRUG
-
Placebo Oral Tablet
Placebo Oral Tablet Duration 18 months 1 tablet (850 mg) PO OD x 30 days then 1 tablet PO BID for duration
Sponsors & Collaborators
-
Prostate Cancer Canada
collaborator OTHER -
British Columbia Cancer Agency
collaborator OTHER -
BC Cancer Foundation
collaborator OTHER -
Canadian Urologic Oncology Group
lead OTHER
Principal Investigators
-
Bernie Eigl, MD · British Columbia Cancer Agency
-
Nawaid Usmani, MD · University of Alberta
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-12
- Primary Completion
- 2023-11-24
- Completion
- 2023-11-24
Countries
- Canada
Study Locations
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