Preoperative Semaglutide Prior to Radical Prostatectomy
United States20 participantsStarted 2026-07
Plain-language summary
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. The trial will also evaluate the safety and tolerability of this preoperative treatment, along with the impact on physiologic/metabolic parameters.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Prostate cancer risk classification other than intermediate risk
* Hemoglobin A1c (HbA1c) \>9%
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
* Baseline gastroparesis, dysphagia, or other significant gastrointestinal disease limiting oral intake
* Current or recent (within 12 months) exposure to GLP-1 receptor agonist therapy
* Delay of radical prostatectomy by 3-6 months is not deemed advisable by the investigator
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Caspase-3 (CC3) activation between baseline biopsy and radical prostatectomy specimen
Timeframe: Baseline (pre-treatment biopsy) through radical prostatectomy, assessed up to 6 months
2
Change in Ki-67 proliferative index between baseline biopsy and radical prostatectomy specimen
Timeframe: Baseline through radical prostatectomy, assessed up to 6 months
3
Change in Gleason score from biopsy to prostatectomy specimen
Timeframe: Baseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months
4
Change in Decipher genomic score in prostate tumor tissue
Timeframe: Baseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months