Semaglutide Before Prostate Surgery for Prostate Cancer

This study is looking at how a medicine called semaglutide (often used for weight management) affects prostate cancer before surgery. You might be able to join if you are a man aged 18 or older with intermediate-risk localized prostate cancer, planning to have a radical prostatectomy (surgery to remove the prostate), have a BMI over 35, and have not had certain hormone therapies. Participants will receive weekly injections of semaglutide for 3-6 months before surgery. Researchers will check changes in cancer cells (like Caspase-3 and Ki-67) and Gleason score between your initial biopsy and the prostate removed during surgery to see if semaglutide has an effect. The study is also looking at the safety of semaglutide and its impact on your body's metabolism.

Study design
This is a single-arm study, meaning all 20 participants will receive semaglutide. It is an exploratory study, not a randomized trial.
What's involved
You would receive weekly subcutaneous (under the skin) injections of semaglutide for 3-6 months before your radical prostatectomy. This involves regular dose adjustments and monitoring.
Compensation
Not stated in the trial record.
Follow-up
Changes in cancer cells will be assessed up to 6 months after your initial biopsy, which includes the time of your radical prostatectomy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07727473

Preoperative Semaglutide Prior to Radical Prostatectomy

Not Yet Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Banner Health
~20 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Semaglutide 2.4 mg

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Caspase-3 (CC3) activation between baseline biopsy and radical prostatectomy specimen
Measured over Baseline (pre-treatment biopsy) through radical prostatectomy, assessed up to 6 months
+3 more outcomes measured
Prostate Cancer
1 sites across 1 states
Arizona1
  • Issac Bowman · PRINCIPAL_INVESTIGATOR · Banner Health

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Eligibility criteria

Inclusion

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

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
  • 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.