Preoperative Semaglutide Prior to Radical Prostatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semaglutide 2.4 mg.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Open-label, Exploratory Interventional Trial of Preoperative Semaglutide Prior to Radical Prostatectomy for Intermediate-risk Localized Prostate Cancer
Overview
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 2.4 mg
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 outcome measures
- 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]
- Change in Ki-67 proliferative index between baseline biopsy and radical prostatectomy specimen [Time frame: Baseline through radical prostatectomy, assessed up to 6 months]
- Change in Gleason score from biopsy to prostatectomy specimen [Time frame: Baseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months]
- Change in Decipher genomic score in prostate tumor tissue [Time frame: Baseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months]
Secondary outcome measures (8)
- Incidence of postoperative complications following radical prostatectomy assessed by Clavien-Dindo classification [Time frame: 30 days and 90 days following radical prostatectomy]
- 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]
- Change in body weight [Time frame: Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months]
- 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]
- Change in hemoglobin A1c (HbA1c) [Time frame: Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months]
- Change in c-peptide levels [Time frame: Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months]
- 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]
- Change in lipid profile parameters [Time frame: Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Banner MD Anderson Cancer Center at Gateway — Gilbert
Identifiers
NCT: NCT07727473 · 2241-2114