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NCT Number: NCT07727473

Preoperative Semaglutide Prior to Radical Prostatectomy

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nibu Mathew

CONTACT

[email protected]

480-256-3425

Sponsors and collaborators

Lead sponsor

Banner Health

Other

Registry information

Official study title

A Prospective, Open-label, Exploratory Interventional Trial of Preoperative Semaglutide Prior to Radical Prostatectomy for Intermediate-risk Localized Prostate Cancer

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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