Preoperative Semaglutide Prior to Radical Prostatectomy

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorBanner Health

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Semaglutide 2.4 mg

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators