Health TrialsbyHealthPanel

Preoperative Semaglutide Prior to Radical Prostatectomy

ConditionProstate Cancer
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Semaglutide Preoperative TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Caspase-3 (CC3) activation between baseline biopsy and radical prostatectomy specimen

Measured via immunohistochemistry on prostate biopsy tissue and radical prostatectomy specimens; change assessed between pre-treatment biopsy and surgical specimen.

Time frame
Baseline (pre-treatment biopsy) through radical prostatectomy, assessed up to 6 months
2

Change in Ki-67 proliferative index between baseline biopsy and radical prostatectomy specimen

Percentage of Ki-67 expression measured via immunohistochemistry; compared between pre-treatment biopsy and radical prostatectomy specimen.

Time frame
Baseline through radical prostatectomy, assessed up to 6 months
3

Change in Gleason score from biopsy to prostatectomy specimen

Pathologic Gleason Score assessed using the Gleason Grading System (score range 6-10). Higher scores indicate more aggressive prostate cancer pathology.

Time frame
Baseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months
4

Change in Decipher genomic score in prostate tumor tissue

Decipher Genomic Classifier Score (continuous scale ranging from 0 to 1.0). Higher scores indicate greater risk of adverse oncologic outcomes.

Time frame
Baseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months

Secondary outcomes

1

Incidence of postoperative complications following radical prostatectomy assessed by Clavien-Dindo classification

Postoperative complications graded using the Clavien-Dindo Classification System (Grade I-V). Higher grades indicate more severe postoperative complications.

Time frame
30 days and 90 days following radical prostatectomy
2

Incidence of Grade 2 or higher adverse events as assessed by CTCAE criteria

Treatment-emergent adverse events graded according to CTCAE criteria; includes events occurring during semaglutide treatment and postoperative follow-up.

Time frame
From initiation of semaglutide through 90 days post-radical prostatectomy
3

Change in body weight

Measured in kilograms and compared between baseline and preoperative assessment.

Time frame
Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months
4

Change in body mass index (BMI)

BMI (kg/m²) calculated and compared between baseline and preoperative assessment.

Time frame
Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Banner Health

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: