A Randomized Phase 3 Trial of Metformin in Patients Initiating Androgen Deprivation Therapy as Prevention and Intervention of Metabolic Syndrome: The PRIME Study
Abstract
Purpose: We investigated whether metformin decreases metabolic syndrome (MS) risk in patients with prostate cancer (PCa) receiving androgen deprivation therapy (ADT).
Materials and methods: In this phase 3, multicenter, double-blind, randomized controlled trial, normoglycemic patients with PCa planned for at least 9 months of ADT were randomized 2:1 to receive metformin 850 mg or placebo twice daily orally for 18 months. The primary objective was to compare proportions of MS at 18 months between the study arms.
Results: Between July 2018 and November 2023, 166 patients were randomized. The trial closed prematurely on November 24, 2023, because of drug supply cessation and the planned enrollment numbers (n = 300) were not met. A total of 90 (metformin) and 45 patients (placebo) were analyzed in the final analysis. The median follow-up was 24 months (IQR: 19.5-36 months). 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). Significant reductions in mean (SD) body weight occurred with metformin at 9 (-0.9 [4] vs +1.8 [3.8] kg; P P = .004). Mean (SD) hemoglobin A1c was lowered with metformin at 9% (-0.02% [0.23%] vs +0.08% [0.26%]; P = .02) and 12 months (+0.03% [0.27%] vs +0.08% [0.27%]; P = .03). Significantly smaller increments in mean (SD) waist circumferences were noted with metformin at 9 (+0.8 [4.3] vs +2.9 [5.7] cm; P = .03), 12 (+1.9 [5.1] vs +3.3 [6] cm; P =…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 300 participants or records.
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