Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-01 @ 2:58 AM
Study NCT ID:
NCT07477756
Status:
COMPLETED
Last Update Posted:
2026-03-19
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-world Study of Characteristics, Treatment Patterns, and Clinical Outcomes Among Lutetium-177 Vipivotide Tetraxetan Treated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1247}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients by Patient Characteristic', 'timeFrame': 'Baseline', 'description': 'Patient characteristics included:\n\n* Age\n* Race\n* Marital status\n* Insurance status\n* Practice type\n* Physician specialty\n* Geographic region\n* Have a Gleason score ≤1 year of index\n* Gleason score (\\<7, ≥7)\n* Have a prostate-specific antigen (PSA) test ≤1 year of index\n* PSA level (elevated, normal, unknown)'}, {'measure': 'Mean PSA Level', 'timeFrame': 'Baseline'}, {'measure': 'Number of Patients by Number of ARPIs and Taxanes Received Before 177Lu-PSMA-617 Treatment Initiation', 'timeFrame': 'Baseline'}, {'measure': 'Number of Patients by Number of Doses of 177Lu-PSMA-617 Treatment From Initiation Until Discontinuation', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Duration of 177Lu-PSMA-617 Treatment', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Number and Percentage of Patients Initiating ARPIs, Taxanes, and Other Guideline-recommended Therapies for mCRPC After 177Lu-PSMA-617 Discontinuation', 'timeFrame': 'Up to approximately 2 years'}], 'secondaryOutcomes': [{'measure': 'Number and Percentage of Patients With a Reduction in PSA Level', 'timeFrame': 'Baseline up to approximately 2 years', 'description': 'Reduction in PSA level was categorized as follows:\n\n* ≥50% (PSA50) reduction in PSA level\n* ≥80% (PSA80) reduction in PSA level\n* ≥90% (PSA90) reduction in PSA level'}]}, 'conditionsModule': {'keywords': ['Lutetium-177 (177Lu) Vipivotide Tetraxetan', '177Lu-PSMA-617', 'Clinical Outcomes', 'Prostate Cancer', 'Prostate-specific Antigen', 'Metastatic Castration-resistant Prostate Cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18428', 'label': 'Link to study results'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to assess the characteristics, treatment patterns, and clinical outcomes among metastatic castration-resistant prostate cancer (mCRPC) patients in the United States (US) who were treated with lutetium-177 vipivotide tetraxetan (177Lu-PSMA-617) in the real-world setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients with evidence of treatment with 177Lu-PSMA-617.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Evidence of 177Lu-PSMA-617 use on or after March 23, 2022\n* Date of initiation of 177Lu-PSMA-617 available in the data\n* Age ≥18 years at index\n\nExclusion criteria:\n\n• None'}, 'identificationModule': {'nctId': 'NCT07477756', 'briefTitle': 'A Real-world Study of Characteristics, Treatment Patterns, and Clinical Outcomes Among Lutetium-177 Vipivotide Tetraxetan Treated Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Real-World Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients Receiving Lutetium-177 Vipivotide Tetraxetan', 'orgStudyIdInfo': {'id': 'CAAA617A1US13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Overall 177Lu-PSMA-617 Cohort', 'description': 'All patients treated with 177Lu-PSMA-617.'}, {'label': 'Prior Treatment Use Cohort: ≥1 Androgen Receptor Pathway Inhibitor (ARPI) and ≥1 Taxane', 'description': 'Patients treated with 177Lu-PSMA-617 after at least 1 ARPI and at least 1 taxane treatment. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel.'}, {'label': 'Prior Treatment Use Cohort: 1 ARPI and 1 Taxane', 'description': 'Patients treated with 177Lu-PSMA-617 after 1 ARPI and 1 taxane treatment. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel.'}, {'label': 'Prior Treatment Use Cohort: Delayed', 'description': 'Patients with evidence of 1 ARPI and 1 taxane treatment plus at least 1 additional ARPI or taxane before 177Lu-PSMA-617 initiation. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel.'}, {'label': 'Subsequent Treatment Use Cohort: Any Guideline-Recommended Treatment', 'description': 'Patients treated with any guideline-recommended treatment for mCRPC after 177Lu-PSMA-617 discontinuation. Guideline-recommended treatments include abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel, pembrolizumab, sipuleucel-T, niraparib, olaparib, talazoparib, rucaparib, radium-223; carboplatin, cisplatin, etoposide, and mitoxantrone.'}, {'label': 'Subsequent Treatment Use Cohort: ARPI/Taxane', 'description': 'Patients treated with any ARPI or taxane after 177Lu-PSMA-617 discontinuation (i.e., abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel).'}, {'label': 'Subsequent Treatment Use Cohort: ARPI', 'description': 'Patients treated with any ARPI after 177Lu-PSMA-617 discontinuation (i.e., abiraterone, enzalutamide, darolutamide, apalutamide).'}, {'label': 'Subsequent Treatment Use Cohort: Taxane', 'description': 'Patients treated with any taxane after 177Lu-PSMA-617 discontinuation (i.e., cabazitaxel, docetaxel).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}