Metformin for Prevention of Anthropometric & Metabolic Complications of Androgen Deprivation Therapy in Prostate Cancer Patients Receiving Radical Radiotherapy: A Phase II Randomized Controlled Trial
Abstract
BACKGROUND
Prostate cancer patients undergoing treatment with radical radiotherapy (RT) plus androgen deprivation therapy (ADT) experience a constellation of deleterious metabolic and anthropometric changes related to hypogonadism that are associated with increased morbidity and mortality. We assessed the impact of metformin versus placebo to blunt the adverse impact of ADT on body weight, waist circumference, and other metabolic parameters.
METHODS AND MATERIALS
This phase 2, multicenter, randomized controlled trial (RCT) randomized normoglycemic men with locally advanced prostate cancer receiving radical RT and ADT (18 to 36 months) in a 1:1 ratio to receive Metformin 500mg by mouth three times a day (for 30 to 36 months) versus identical placebo.
RESULTS
From December 2015 to October 2019, 83 men were randomized with median follow-up of 23 months. Baseline mean body mass Index (BMI) of the cohort was 30.2 (range 22.2-52.5). Change in mean weight relative to baseline was lower amongst men who received metformin compared to placebo at 5 months (-1.80 kg, p=0.038), but was not significant with longer follow-up (1 year: +0.16 kg, p=0.874). Although participants on ADT had increases in waist circumference in both study arms, metformin did not significantly reduce these changes (1 year: +2.79 cm (placebo) vs. +1.46 cm (metformin), p=0.336). LDL cholesterol was lower in the metformin arm (-0.32 mmol/L) when compared to the placebo arm (-0.03 mmol/L) at 5 months (p=0.022), but…
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.
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