Preoperative Semaglutide Prior to Radical Prostatectomy

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Banner Health
Study ID
NCT07727473
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jul 27, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
May 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide Preoperative Treatment
    Participants enrolled in this single-arm study will receive weekly subcutaneous semaglutide for 3 to 6 months prior to planned radical prostatectomy. Semaglutide will be administered according to the FDA-approved dosing regimen, with dose titration as tolerated. Treatment will be discontinued one week prior to surgery, after which participants will proceed with standard-of-care radical prostatectomy and postoperative follow-up.

Primary Outcome 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer Center at GatewayGilbertArizona85234
Clinical Trials Senior Manager
[email protected]
602-747-3647
Director, Clinical Trials
[email protected]

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Prostate cancer
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By research site
Banner MD Anderson Cancer Center at Gateway· Gilbert, AZ

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