Clinical trial

Preoperative Semaglutide Prior to Radical Prostatectomy

Opening soon · Early Phase 1 · 1 countries · Registry ID NCT07727473

Opening soonEarly Phase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexMale

Healthy volunteersNot accepted

ConditionProstate Cancer

Full registry criteria

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

Treatments and study arms

Semaglutide 2.4 mg

Drug

Semaglutide will be administered as a weekly subcutaneous injection. The dose will be titrated according to the FDA-approved labeling, starting at 0.25 mg once weekly and increasing as tolerated to a target maintenance dose of up to 2.4 mg once weekly. Treatment will continue for 3 to 6 months prior to planned radical prostatectomy.

Primary outcomes

Change in Caspase-3 (CC3) activation between baseline biopsy and radical prostatectomy specimenBaseline (pre-treatment biopsy) through radical prostatectomy, assessed up to 6 months

Measured via immunohistochemistry on prostate biopsy tissue and radical prostatectomy specimens; change assessed between pre-treatment biopsy and surgical specimen.

Change in Ki-67 proliferative index between baseline biopsy and radical prostatectomy specimenBaseline through radical prostatectomy, assessed up to 6 months

Percentage of Ki-67 expression measured via immunohistochemistry; compared between pre-treatment biopsy and radical prostatectomy specimen.

Change in Gleason score from biopsy to prostatectomy specimenBaseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months

Pathologic Gleason Score assessed using the Gleason Grading System (score range 6-10). Higher scores indicate more aggressive prostate cancer pathology.

Change in Decipher genomic score in prostate tumor tissueBaseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months

Decipher Genomic Classifier Score (continuous scale ranging from 0 to 1.0). Higher scores indicate greater risk of adverse oncologic outcomes.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Banner MD Anderson Cancer Center at Gateway🇺🇸 Gilbert, Arizona, United States

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Clinical Trials Senior ManagerContact

Email · Call 602-747-3647

Director, Clinical TrialsContact