drugset / Trial / NCT03031821
Metformin in Patients Initiating ADT as Prevention and Intervention of Metabolic Syndrome
Phase 3
Terminated
168 enrolled
Canadian Urologic Oncology Group
BC Cancer Foundation · collabBritish Columbia Cancer Agency · collabProstate Cancer Canada · collab
RandomizedParallel-groupQuadruple-blindPrevention
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).
Timeline
- Start
- 2018-07-12
- Primary completion
- 2023-11-24
- Completion
- 2023-11-24
Outcome
Missed primary endpoint
Stopped: “Manufacturer discontinued the production of study drugs.”
paper CONCLUSIONS: Metformin did not reduce the risk of MS in patients with PCa on ADT. PMID 40711960 ↗
paper Proportions of MS between metformin and placebo arms were 38/90 (42%) vs 26/45 (58%) at baseline (P = .09) and 40/73 (55%) vs 23/34 (68%) at 18 months (P = .2). PMID 40711960 ↗
Publications
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- Background Foretz M, Guigas B, Bertrand L, Pollak M, Viollet B. Metformin: from mechanisms of action to therapies. Cell Metab. 2014 Dec 2;20(6):953-66. doi: 10.1016/j.cmet.2014.09.018. Epub 2014 Oct 30.
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- Eigl BJ, Elangovan A, Ghosh S, Kim JO, Thoms J, Bouchard M, Peacock M, Fleshner N, Campbell H, Vigneault E, Vincent F, So A, Cury F, Quon H, Carlson R, Lambert C, Klotz L, Chi K, Brundage M, Pollak M, Rebane L, Chiu L, Courneya KS, Usmani N. A Randomized Phase 3 Trial of Metformin in Patients Initiating Androgen Deprivation Therapy as Prevention and Intervention of Metabolic Syndrome: The PRIME Study. J Urol. 2025 Nov;214(5):496-508. doi: 10.1097/JU.0000000000004695. Epub 2025 Jul 25.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 850 mg | Oral |