Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-19 @ 9:56 PM
Study NCT ID:
NCT05169112
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2021-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy
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': 'D016729', 'term': 'Leuprolide'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2021-03-01', 'studyFirstSubmitQcDate': '2021-12-22', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of enrolment', 'timeFrame': '1 year', 'description': 'Rate (patients/month) of enrolment'}], 'secondaryOutcomes': [{'measure': 'Rate of enrolment per site', 'timeFrame': '1 year', 'description': 'Rate (patients/month) of enrolment per site'}, {'measure': 'Proportion of patients completing study intervention per-protocol', 'timeFrame': '1 year', 'description': 'Proportion of patients completing study intervention per-protocol'}, {'measure': 'Time to study start-up', 'timeFrame': '1 year', 'description': 'Time to study start-up at each site'}, {'measure': 'Completeness of study assessments', 'timeFrame': '1 year', 'description': 'Proportion of study assessments completed per-protocol'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Prostate cancer is the most common cancer in men and radical prostatectomy is the most frequent treatment for this disease. Unfortunately, approximately 40% of patients will develop recurrence after surgery, requiring additional salvage radiation. Salvage radiation after recurrence is successful in less than half of these men and most of those die from their disease. Measures to prevent recurrence are an important research priority for prostate cancer patients and their families. Hormonal therapy (androgen deprivation therapy; ADT) is routinely used to treat patients with metastases, but few clinical trials have examined if adjuvant ADT after surgery will prevent cancer recurrence. We aim to address this research oversight and test the hypothesis that for men at high risk of cancer recurrence, 1 year of ADT immediately after surgery will be safe and will significantly improve cancer outcomes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. undetectable PSA (\\<0.02 ng/ml) within 16 weeks post-operative;\n2. ≥25% predicted risk of PSA recurrence within 5 years of surgery (based on the Kattan nomogram)\n\nExclusion Criteria:\n\n1. Unwilling to receive ADT;\n2. previously received ADT;\n3. lymph node metastases\n4. allergy to any form of ADT'}, 'identificationModule': {'nctId': 'NCT05169112', 'briefTitle': 'Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'The Impact of Adjuvant Androgen Deprivation Following Radical Prostatectomy on Prostate Cancer Recurrence', 'orgStudyIdInfo': {'id': 'Adjuvant ADT Pilot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Standard of Care'}, {'type': 'EXPERIMENTAL', 'label': 'Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)', 'description': '22.5 mg intra-muscular injection of Lupron Depot every 3 months for 12 months (4 injections total)', 'interventionNames': ['Drug: Lupron Depot']}], 'interventions': [{'name': 'Lupron Depot', 'type': 'DRUG', 'description': 'Patients randomized to receive androgen deprivation therapy (ADT) will receive 12 months of Lupron Depot (22.5 mg) administered every 3 months', 'armGroupLabels': ['Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ricardo Rendon, MD', 'role': 'CONTACT', 'email': 'Ricardo.Rendon@nshealth.ca', 'phone': '902-425-3940'}, {'name': 'Ricardo Rendon, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nova Scotia Health', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Rodney H Breau, MD, FRCSC', 'role': 'CONTACT', 'email': 'rbreau@ottawahospital.on.ca', 'phone': '613-737-8899', 'phoneExt': '73019'}, {'name': 'Pascale Juneau, MASc', 'role': 'CONTACT', 'email': 'pjuneau@ohri.ca', 'phone': '613-737-8899', 'phoneExt': '73852'}, {'name': 'Rodney H Breau, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'facility': 'Centre universitaire de santé McGill - McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Rodney Breau, Dr.', 'role': 'CONTACT', 'email': 'rbreau@toh.on.ca', 'phone': '613-737-8899', 'phoneExt': '73019'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'N/A. IPD not planned to be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tolmar Pharmaceuticals', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Rodney Breau', 'investigatorAffiliation': 'Ottawa Hospital Research Institute'}}}}