Prostate CancerEarly Phase 1NCT07727473
Preoperative Semaglutide Prior to Radical Prostatectomy
A Early Phase 1 study testing Semaglutide 2.4 mg in people with Prostate Cancer, run by Banner Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Semaglutide 2.4 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to May 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Banner MD Anderson Cancer Center at Gateway
Gilbert, Arizona, 85234
Clinical Trials Senior Manager, 602-747-3647, nibu.mathew@bannerhealth.com
Director, Clinical Trials, klarissa.jones@bannerhealth.com
About this study
Official title: A Prospective, Open-label, Exploratory Interventional Trial of Preoperative Semaglutide Prior to Radical Prostatectomy for Intermediate-risk Localized Prostate Cancer
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.
- Conditions
- Prostate Cancer
- Being tested
- Semaglutide 2.4 mg
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 2.4 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide Preoperative Treatment | Experimental | Participants enrolled in this single-arm study will receive weekly subcutaneous semaglutide for 3 to 6 months prior to planned radical prostatectomy. Semaglutide will be administered according to the FDA-approved dosing regimen, with dose titration as tolerated. Treatment will be discontinued one week prior to surgery, after which participants will proceed with standard-of-care radical prostatectomy and postoperative follow-up. Receives: Drug: Semaglutide 2.4 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Percentage of Ki-67 expression measured via immunohistochemistry; compared between pre-treatment biopsy and radical prostatectomy specimen.
Measured: Baseline through radical prostatectomy, assessed up to 6 months
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.
Measured: Baseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months
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.
Measured: Baseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months
Secondary outcomes (8)
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.
Measured: 30 days and 90 days following radical prostatectomy
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.
Measured: From initiation of semaglutide through 90 days post-radical prostatectomy
Change in body weight
Measured in kilograms and compared between baseline and preoperative assessment.
Measured: Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months
Change in body mass index (BMI)
BMI (kg/m²) calculated and compared between baseline and preoperative assessment.
Measured: Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months
Change in hemoglobin A1c (HbA1c)
Measured via blood testing and compared between baseline and preoperative assessment.
Measured: Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months
Change in c-peptide levels
Measured via blood testing and compared between baseline and preoperative assessment.
Measured: 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)
Measured via blood testing and compared between baseline and preoperative assessment.
Measured: Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months
Change in lipid profile parameters
Includes total cholesterol, LDL, HDL, and triglycerides measured by blood testing and compared between baseline and preoperative assessment.
Measured: Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Banner Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Issac Bowman, Principal investigator, Banner Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727473
- Sponsor's protocol ID
- 2241-2114
- Status last verified
- Jul 2026
- First submitted
- 13 May 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Exploratory Interventional Trial of Preoperative Semaglutide Prior to Radical Prostatectomy for Intermediate-risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT07727473
- Acronym / sponsor ID
- 2241-2114
- Conditions
- Prostate Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Banner HealthUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semaglutide Preoperative Treatment | Experimental | Drug: Semaglutide 2.4 mgParticipants enrolled in this single-arm study will receive weekly subcutaneous semaglutide for 3 to 6 months prior to planned radical prostatectomy. Semaglutide will be administered according to the FDA-approved dosing regimen, with dose titration as tolerated. Treatment will be discontinued one week prior to surgery, after which participants will proceed with standard-of-care radical prostatectomy and postoperative follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide 2.4 mgSemaglutide 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. | Drug | Semaglutide Preoperative Treatment |
Primary outcome
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.
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.
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.
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Issac Bowman principal investigator
Banner Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Semaglutide 2.4 mg in people with Prostate Cancer, run by Banner Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nibu Mathew (480-256-3425, nibu.mathew@bannerhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.