Status
Not yet recruiting
Phase
Early Phase 1
Enrollment
20
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
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.
Timeline
First posted
Jul 27, 2026
Study start
Jul 2026
Primary completion
May 2028
Study completion
May 2029
Results posted
Not reported
Registry updated
Jul 27, 2026
Outcomes
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
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 specimen
Time frame · Baseline 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 specimen
Time frame · Baseline 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 tissue
Time frame · Baseline 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.
Incidence of postoperative complications following radical prostatectomy assessed by Clavien-Dindo classification
Time frame · 30 days and 90 days following radical prostatectomy
Postoperative complications graded using the Clavien-Dindo Classification System (Grade I-V). Higher grades indicate more severe postoperative complications.
Incidence of Grade 2 or higher adverse events as assessed by CTCAE criteria
Time frame · From initiation of semaglutide through 90 days post-radical prostatectomy
Treatment-emergent adverse events graded according to CTCAE criteria; includes events occurring during semaglutide treatment and postoperative follow-up.
Change in body weight
Time frame · Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months
Measured in kilograms and compared between baseline and preoperative assessment.
Change in body mass index (BMI)
Time frame · Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months
BMI (kg/m²) calculated and compared between baseline and preoperative assessment.
Change in hemoglobin A1c (HbA1c)
Time frame · Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months
Measured via blood testing and compared between baseline and preoperative assessment.
Change in c-peptide levels
Time frame · Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months
Measured via blood testing and compared between baseline and preoperative assessment.
Change in high-sensitivity C-reactive protein (hsCRP)
Time frame · Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months
Measured via blood testing and compared between baseline and preoperative assessment.
Change in lipid profile parameters
Time frame · Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months
Includes total cholesterol, LDL, HDL, and triglycerides measured by blood testing and compared between baseline and preoperative assessment.
Eligibility
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Banner MD Anderson Cancer Center at Gateway
Gilbert, Arizona, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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