Semaglutide's Impact on Cardiovascular Risk and Prostate Biomarkers in Men on ADT to be Investigated

Men with prostate cancer often undergo androgen deprivation therapy (ADT), a highly effective treatment that unfortunately carries significant metabolic side effects. ADT can lead to weight gain, increased visceral fat, dyslipidemia, insulin resistance, and elevated blood pressure, substantially raising the risk of cardiovascular disease. Current strategies to mitigate these risks are often insufficient, leaving a critical gap in patient care. Glucagon-Like Peptide-1 Receptor Agonists (GLP-1R agonists) like semaglutide are known for their potent effects on glucose homeostasis, weight loss, and cardiovascular protection, making them a promising candidate to address ADT-induced metabolic dysfunction.

The GAIN PC CONTROL study is an open-label, single-arm, Phase IV clinical trial investigating Semaglutide in 20 men with prostate cancer receiving androgen deprivation therapy (ADT). Participants will receive Semaglutide subcutaneously once weekly, starting at 0.25mg for weeks 1-4, escalating to 0.5mg (weeks 5-8), 1mg (weeks 9-12), 1.7mg (weeks 13-16), and finally 2.4mg for the remainder of the 12-month trial. Primary endpoints include safety and tolerability, alongside changes in weight, waist circumference, blood pressure, HbA1c, lipids, PSA, creatinine, and estimated glomerular filtration rate (eGFR).

This ongoing Phase IV trial aims to establish the safety and tolerability of Semaglutide in 20 men with prostate cancer undergoing androgen deprivation therapy (ADT). Researchers will evaluate its effects on key metabolic and prostate health markers over a 12-month period. Specifically, the study seeks to quantify changes in body weight, waist circumference, blood pressure, HbA1c, and lipid profiles. The trial is designed to provide preliminary data on whether GLP-1R agonism can mitigate ADT-induced metabolic side effects while monitoring for any influence on prostate cancer progression markers. Secondary outcomes include changes in creatinine and estimated glomerular filtration rate (eGFR), providing insights into renal function. The study is currently recruiting participants, with an estimated completion date of 2026-07-31.