Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 11:44 PM
Study NCT ID:
NCT06908694
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2025-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer Taking Androgen Deprivation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label single-arm phase IV trial.\n\nFollowing enrolment, all participants will undergo a baseline visit, a 1-month telephone follow-up visit, 3-month visit, 6-month and 12-month (Close-out) visit.\n\nThe semaglutide dose will be 0.25mg subcutaneously once weekly for weeks 1-4, then 0.5mg once weekly for weeks 5-8, then 1mg once weekly for weeks 9-12, then 1.7mg once weekly for weeks 13-16, and then 2.4mg for the remainder of the trial. Semaglutide dose may be decreased in the case of adverse events to the highest tolerated dose.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Serious Adverse Events', 'timeFrame': '12 months', 'description': 'An event that leads to death; is life-threatening; results in hospitalization or its prolongation; disability or permanent damage; congenital anomaly or birth defect; or other medical event that is considered serious.'}, {'measure': 'Number of Adverse Events leading to Drug Discontinuation', 'timeFrame': '6 months', 'description': 'Adverse Events leading to Drug Discontinuation'}, {'measure': 'Measure of Weight', 'timeFrame': '12 months', 'description': 'Measure of Weight'}, {'measure': 'Measure of Waist Circumference', 'timeFrame': '12 months', 'description': 'Measure of Waist Circumference'}, {'measure': 'Measure of Blood Pressure', 'timeFrame': '12 months', 'description': 'Measure of Blood Pressure'}, {'measure': 'Concentration of HbA1c', 'timeFrame': '12 months', 'description': 'Concentration of HbA1c'}, {'measure': 'Concentration of Lipids', 'timeFrame': '12 months', 'description': 'Total Cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides'}, {'measure': 'Concentration of PSA', 'timeFrame': '12 months', 'description': 'Concentration of PSA'}, {'measure': 'Concentration of Creatinine', 'timeFrame': '12 months', 'description': 'Concentration of Creatinine'}, {'measure': 'Calculation of estimated glomerular rate', 'timeFrame': '12 months', 'description': 'Calculation of estimated glomerular rate'}, {'measure': 'Number of Clinical Outcomes', 'timeFrame': '12 months', 'description': 'Death, Hospitalization, New Diabetes, Myocardial Infarction, Stroke, Heart Failure, Peripheral Arterial Disease, Venous Thromboembolism'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Androgen Deprivation Therapy', 'GLP-1 Receptor Agonists'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'GAIN PC CONTROL is a study investigating Glucagon-Like Peptide-1 Receptor Agonists in men with prostate cancer who are being treated with androgen deprivation therapy.', 'detailedDescription': 'GAIN PC CONTROL is an open-label single-arm phase IV trial that will evaluate 1) the safety and tolerability of Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) in men with prostate cancer (PC) treated with androgen deprivation therapy (ADT); 2) the effects of GLP-1 RAs on weight, waist circumference, blood pressure, HbA1c, lipids, PSA and Creatinine, estimated glomerular filtration rate in men with PC treated with ADT.\n\nPatients who meet eligibility criteria and who provide informed consent will be enrolled to receive semaglutide.\n\nFollowing enrollment, all participants will undergo a baseline visit, a 1-month telephone follow-up visit, 3-month visit, 6-month and a 12-month (Close-out) visit.\n\nThe semaglutide dose will be 0.25mg subcutaneously once weekly for weeks 1-4, then 0.5mg once weekly for weeks 5-8, then 1mg once weekly for weeks 9-12, then 1.7mg once weekly for weeks 13-16, and then 2.4mg for the remainder of the trial. Semaglutide dose may be decreased in the case of adverse events to the highest tolerated dose.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a physician diagnosis of PC\n* Must be receiving or planned to receive ADT (gonadotropin releasing hormone agonist or antagonist ± androgen receptor pathway inhibitor)\n* Elevated BMI\n\n 1. ≥30kg/m2 or\n 2. ≥27kg/m2 in the presence of at least one of hypertension, type 2 diabetes, obstructive sleep apnea or dyslipidemia\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Taking a GLP-1 RA\n* \\<18 years of age\n* History of pancreatitis\n* Personal or family history of medullary cancer of the thyroid\n* Multiple endocrine neoplasia type 2'}, 'identificationModule': {'nctId': 'NCT06908694', 'acronym': 'GAINPCCONTROL', 'briefTitle': 'Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer Taking Androgen Deprivation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Hamilton Health Sciences Corporation'}, 'officialTitle': 'GLP1-Receptor Agonists in Men With Prostate Cancer: Control of Cardiovascular Risk Factors and Prostate Biomarkers', 'orgStudyIdInfo': {'id': '5100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semaglutide', 'description': 'The semaglutide dose will be 0.25mg subcutaneously once weekly for weeks 1-4, then 0.5mg once weekly for weeks 5-8, then 1mg once weekly for weeks 9-12, then 1.7mg once weekly for weeks 13-16, and then 2.4mg for the remainder of the trial. Semaglutide dose may be decreased in the case of adverse events to the highest tolerated dose.', 'interventionNames': ['Drug: Semaglutide Pen Injector']}], 'interventions': [{'name': 'Semaglutide Pen Injector', 'type': 'DRUG', 'otherNames': ['Wegovy®'], 'description': 'The semaglutide dose will be 0.25mg subcutaneously once weekly for weeks 1-4, then 0.5mg once weekly for weeks 5-8, then 1mg once weekly for weeks 9-12, then 1.7mg once weekly for weeks 13-16, and then 2.4mg for the remainder of the trial. Semaglutide dose may be decreased in the case of adverse events to the highest tolerated dose.', 'armGroupLabels': ['Semaglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8V1C3', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Nadra Yasmin', 'role': 'CONTACT', 'email': 'nadra.yasmin@phri.ca'}, {'name': 'Shauna Szendrey', 'role': 'CONTACT', 'email': 'szendreys@hhsc.ca'}, {'name': 'Darryl Leong, MBBs,MPH,PhD,FRACP,FESC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jehonathan Pinthus, MD,FRCS(C),PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Sarah Karampatos, BASc, MSc', 'role': 'CONTACT', 'email': 'sarah.karampatos@phri.ca', 'phone': '905-296-5795'}, {'name': 'Steven Agapay, BSc', 'role': 'CONTACT', 'email': 'steve.agapay@phri.ca', 'phone': '905-296-5764'}], 'overallOfficials': [{'name': 'Darryl Leong, MBBs,MPH,PhD,FRACP,FESC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Population Health Research Institute and McMaster University'}, {'name': 'Jehonathan Pinthus, MD,FRCS(C),PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Juravinski Cancer Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'McMaster University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}