Preoperative Semaglutide Prior to Radical Prostatectomy

What Was Tested

In this early phase 1 trial, researchers set out to test Semaglutide.

In this exploratory, single-arm, nonrandomized trial, the impact of the preoperative utilization of the glucagon-like peptide-1 (GLP-1) receptor agonist (RA) semaglutide prior to radical prostatectomy in participants with intermediate risk prostate cancer will be investigated.

Semaglutide will be administered according to the FDA-approved label for chronic weight management and participants will be dosed with a weekly subcutaneous injection.

The primary aim of this trial is to explore the tumor biological activity of semaglutide in these participants.

It had 1 arm (groups): Semaglutide Preoperative Treatment (experimental).

The registry classes the interventions as drug.

Who Took Part

20 planned participants were the target.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male participants aged ≥18 years. Biopsy-proven intermediate-risk localized prostate cancer per NCCN risk stratification criteria. Planning to undergo radical prostatectomy, and surgical delay of 3-6 months is deemed appropriate by the investigator. Body mass index (BMI) \>35 kg/m². No prior exposure to androgen deprivation therapy or androgen receptor pathway inhibitors.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: prostate cancer risk classification other than intermediate risk; personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2); current or recent (within 12 months) exposure to glp-1 receptor agonist therapy.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Semaglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-07 with completion listed for 2028-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Caspase-3 (CC3) activation between baseline biopsy and radical prostatectomy specimen (time frame: Baseline (pre-treatment biopsy) through radical prostatectomy, assessed up to 6 months). Change in Ki-67 proliferative index between baseline biopsy and radical prostatectomy specimen (time frame: Baseline through radical prostatectomy, assessed up to 6 months). Change in Gleason score from biopsy to prostatectomy specimen (time frame: Baseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months).

It also tracked 8 secondary outcomes, for example Incidence of postoperative complications following radical prostatectomy assessed by Clavien-Dindo classification, Incidence of Grade 2 or higher adverse events as assessed by CTCAE criteria, Change in body weight, Change in body mass index (BMI), Change in hemoglobin A1c (HbA1c) and Change in c-peptide levels.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Semaglutide in 20 people.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.