NCT07727473Not yet recruitingEarly phase 1
Preoperative Semaglutide Prior to Radical Prostatectomy
A Prospective, Open-label, Exploratory Interventional Trial of Preoperative Semaglutide Prior to Radical Prostatectomy for Intermediate-risk Localized Prostate Cancer
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 13 May 2026
- Start date
- Jul 2026
- Primary completion date
- May 2028
- Lead sponsor
- Banner Health
- Diseases
- Prostate cancer
- NCT number
- NCT07727473
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 20
- From Jul 2026 to the primary completion date, May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or recent (within 12 months) exposure to GLP-1 receptor agonist therapy
Other illness
- Prostate cancer risk classification other than intermediate risk
- 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
Lab values
- Hemoglobin A1c (HbA1c) \>9%
Other
- Delay of radical prostatectomy by 3-6 months is not deemed advisable by the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Banner MD Anderson Cancer Center at Gateway Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.