Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT06824818
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess the Feasibility of Stopping Prostate Cancer Treatment Early in Elderly Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study follows a \\*\\*single-group assignment\\*\\* model, where all participants discontinue LHRH agonist therapy and are monitored for testosterone and PSA levels over 3 years to assess the feasibility of this approach.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 155}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2025-02-12', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'feasibility of stopping LHRH agonist therapy', 'timeFrame': '12 months after discontinuing LHRH agonist therapy', 'description': 'Fraction of patients maintaining castrate testosterone levels'}], 'secondaryOutcomes': [{'measure': 'Patient interest in stopping treatment', 'timeFrame': 'End of enrollment (approximately 3 years after study start)', 'description': 'Percentage of patients that decline participation in the study'}, {'measure': 'Medication Impact', 'timeFrame': 'End of study (approximately 3 years after last participant is enrolled)', 'description': 'Percentage of participants that start other prostate cancer treatments before starting or during the study'}, {'measure': 'Impact on Testosterone Levels (12 months)', 'timeFrame': '12 months after last participant starts study', 'description': 'Percentage of participants with testosterone levels \\<20 ng/ml'}, {'measure': 'Impact on Testosterone Levels (36 months)', 'timeFrame': '36 months after last participant starts study', 'description': 'Percentage of participants with testosterone levels \\<20 ng/ml'}, {'measure': 'Health Care Savings', 'timeFrame': 'End of study (approximately 3 years after last participant is enrolled)', 'description': 'Cost savings per participant measured by cost of the drug (e.g. how much was saved by participants not taking drug during the study period)'}, {'measure': 'Visit Compliance', 'timeFrame': 'End of study (approximately 3 years after last participant is enrolled)', 'description': 'Percentage of missed visits during study compared to number of routine visits missed in 12 month period prior to starting study'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elderly', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This study seeks to identify if it is feasible to stop Luteinizing Hormone-Releasing Hormone (LHRH) Agonist Therapy in elderly men with prostate cancer. We hypothesize that elderly prostate cancer patients on long term androgen ablation with LHRH agonists will be permanently castrated and do not require ongoing LHRH agonist therapy. Participants will be monitored by testosterone testing throughout study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prostate cancer with \\>3 years of LHRH agonist therapy.\n* Age ≥70 years.\n* ECOG performance status ≤2\n* Baseline testosterone of \\< 20 ng/ml\n* No prior chemotherapy or Lu-PSMA (unless survival predictions are favorable).\n* Ability to understand and sign informed consent.\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06824818', 'briefTitle': 'Study to Assess the Feasibility of Stopping Prostate Cancer Treatment Early in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'A Feasibility Trial of LHRH Agonist Discontinuation in Elderly Prostate Cancer Patients', 'orgStudyIdInfo': {'id': 'IRB24-1729'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'discontinuation of LHRH agonist therapy in elderly prostate cancer patients', 'interventionNames': ['Behavioral: LHRH Agonist Therapy Discontinuation']}], 'interventions': [{'name': 'LHRH Agonist Therapy Discontinuation', 'type': 'BEHAVIORAL', 'description': 'The intervention involves \\*\\*discontinuing LHRH agonist therapy\\*\\* in elderly prostate cancer patients who have been on long-term androgen deprivation therapy. Participants will be monitored for testosterone recovery and PSA levels over a period of up to 3 years.', 'armGroupLabels': ['discontinuation of LHRH agonist therapy in elderly prostate cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'TBD TBD', 'role': 'CONTACT'}, {'name': 'Natalie Reizine, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Illinois at Chicago (UIC)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cancer Clinical Trial Intake', 'role': 'CONTACT', 'email': 'cancerclinicaltrials@bsd.uchicago.edu', 'phone': '855-702-8222'}, {'name': 'Nabiel Mir, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UChicago Medicine Comprehensive Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Clinical Trials Intake', 'role': 'CONTACT', 'email': 'cancerclinicaltrials@bsd.uchicago.edu', 'phone': '1-855-702-8222'}], 'overallOfficials': [{'name': 'Nabiel Mir, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}