Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT06151418
Status:
COMPLETED
Last Update Posted:
2025-06-04
First Post:
2023-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000069501', 'term': 'Abiraterone Acetate'}, {'id': 'C572045', 'term': 'apalutamide'}, {'id': 'C540278', 'term': 'enzalutamide'}], 'ancestors': [{'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquires@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Data for adverse events and death were not planned to be evaluated during the study; hence timeframe is not applicable', 'description': 'Due to non-interventional nature of the study, minimum criteria for reporting an adverse event could not be met, hence adverse events were not planned to be evaluated. Thus, explaining 0 participant at risk.', 'eventGroups': [{'id': 'EG000', 'title': 'Participant: NHT', 'description': 'Eligible participants who initiated NHT as therapy including 1L to treat mCSPC in real world setting from 01-January-2020 to 31-December-2022, their data were evaluated as per objectives of this study. No intervention was administered under this observational study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Therapy (DOT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2313', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participant: NHT', 'description': 'Eligible participants who initiated NHT as therapy including 1L to treat mCSPC in real world setting from 01-January-2020 to 31-December-2022, their data were evaluated as per objectives of this study. No intervention was administered under this observational study.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '19.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of index treatment to date of NHT discontinuation or censoring date, whichever came first, during maximum follow-up of 45 months', 'description': "DOT was defined as the time from the index date to the date of NHT discontinuation for any reason. Discontinuation of the current NHT was defined as a treatment gap of at least 90 days (the last day with days' supply before the gap as discontinuation date), the initiation of a new therapy, or death, whichever came first. Initiation of a new therapy was defined by switching to a different NHT, switching to or augmentation with different therapies. Participants who did not experience discontinuation were censored at the end of data availability. Index date was defined as the initiation date of NHT in 1L (any date) from 1-January-2020 to 31-December-2022. Retrospective data was retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months).", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included eligible participants whose data was retrieved and evaluated per objectives of this study.'}, {'type': 'SECONDARY', 'title': 'Time to Next Therapy (TTNT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2313', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participant: NHT', 'description': 'Eligible participants who initiated NHT as therapy including 1L to treat mCSPC in real world setting from 01-January-2020 to 31-December-2022, their data were evaluated as per objectives of this study. No intervention was administered under this observational study.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI could not be estimated due to insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of index treatment until date of new therapy, or censoring date, whichever came first; during maximum follow-up of 45 months', 'description': "TTNT was defined as the time from the index date to the initiation date of a new therapy. Initiation of a new therapy was defined by switching to a different NHT, switching to different therapies. Participants who did not initiate a new therapy were censored at the end of data availability or death, whichever came first. Index date was defined as the initiation date of NHT in 1L (any date) from 1-January-2020 to 31-December-2022. Retrospective data was retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months). Kaplan-Meier method was used for analysis.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included eligible participants whose data was retrieved and evaluated per objectives of this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participant: NHT', 'description': 'Eligible participants who initiated NHT as therapy including 1L to treat mCSPC in real world setting from 01-January-2020 to 31-December-2022, their data were evaluated as per objectives of this study. No intervention was administered under this observational study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2313'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2313'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Data of participants diagnosed with metastatic castration-sensitive prostate cancer (mCSPC), who initiated Novel Hormonal Therapy (NHT) \\[abiraterone, apalutamide, or enzalutamide\\] in first line (1L) setting, any date (index date) from 01-Jan-2020 to 31-Dec-2022 were retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months). Retrospective data was evaluated from 22-Nov-2023 to 23-Apr-2024 (approximately 5 months) per objectives of the study."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2313', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participant: NHT', 'description': 'Eligible participants who initiated NHT as therapy including 1L to treat mCSPC in real world setting from 01-January-2020 to 31-December-2022, their data were evaluated as per objectives of this study. No intervention was administered under this observational study.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'title': '18-59 Years', 'measurements': [{'value': '99', 'groupId': 'BG000'}]}, {'title': '60-69 Years', 'measurements': [{'value': '451', 'groupId': 'BG000'}]}, {'title': '70-79 Years', 'measurements': [{'value': '1206', 'groupId': 'BG000'}]}, {'title': 'Greater than or equal to (>=) 80', 'measurements': [{'value': '557', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2313', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White, non-Hispanic', 'measurements': [{'value': '1478', 'groupId': 'BG000'}]}, {'title': 'Black', 'measurements': [{'value': '522', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '114', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '137', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data is reported as retrieved from medical records in accordance to protocol.'}], 'populationDescription': 'Analysis population included eligible participants whose data was retrieved and evaluated per objectives of this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-06', 'size': 376806, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-22T11:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2313}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2023-11-21', 'resultsFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2023-11-21', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-02', 'studyFirstPostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Therapy (DOT)', 'timeFrame': 'From start of index treatment to date of NHT discontinuation or censoring date, whichever came first, during maximum follow-up of 45 months', 'description': "DOT was defined as the time from the index date to the date of NHT discontinuation for any reason. Discontinuation of the current NHT was defined as a treatment gap of at least 90 days (the last day with days' supply before the gap as discontinuation date), the initiation of a new therapy, or death, whichever came first. Initiation of a new therapy was defined by switching to a different NHT, switching to or augmentation with different therapies. Participants who did not experience discontinuation were censored at the end of data availability. Index date was defined as the initiation date of NHT in 1L (any date) from 1-January-2020 to 31-December-2022. Retrospective data was retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months)."}], 'secondaryOutcomes': [{'measure': 'Time to Next Therapy (TTNT)', 'timeFrame': 'From start of index treatment until date of new therapy, or censoring date, whichever came first; during maximum follow-up of 45 months', 'description': "TTNT was defined as the time from the index date to the initiation date of a new therapy. Initiation of a new therapy was defined by switching to a different NHT, switching to different therapies. Participants who did not initiate a new therapy were censored at the end of data availability or death, whichever came first. Index date was defined as the initiation date of NHT in 1L (any date) from 1-January-2020 to 31-December-2022. Retrospective data was retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months). Kaplan-Meier method was used for analysis."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metastatic castration-sensitive prostate cancer', 'mCSPC', 'metastatic hormone-sensitive prostate cancer', 'mHSPC', 'enzalutamide', 'abiraterone', 'treatment duration', 'time to next therapy'], 'conditions': ['Prostatic Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C3431052', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to learn about- for how long are NHTs taken by men to treat mCSPC. NHTs in this study include study medicines:\n\n* abiraterone,\n* apalutamide,\n* enzalutamide.\n\nProstate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Metastatic cancer is a cancer that has spread to other parts of the body. Most prostate cancers need male hormones to grow. When cancer cells respond to treatment that lowers male hormones, this is known as castration-sensitive prostate cancer.\n\nThis is a real-world study, not a clinical trial. This means that researchers will look at what happens when men receive the treatments prescribed by their own doctor as part of their usual healthcare treatment. In this study, researchers will use information from National Veteran's Affairs (VA) Health Care Network.\n\nThe study will include patients' information from the database for men who:\n\n* were identified to have mCSPC.\n* started treatment with NHT for mCSPC.\n* were 18 years of age or older at start of NHT.\n\nMen in this study will be taking NHT for treatment of their mCSPC. The study will explain:\n\n* how long men take the therapy.\n* how long it takes to start next therapy.\n\nThis study will use patient information about medications and treatments from VA data. This study will use information one year before start of NHT until information is available."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men with metastatic castration-sensitive prostate cancer who initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) and met eligibility criteria will be included in the study. Patients will be identified from the National Veterans Affairs Health Care Network.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male with ≥ 1 diagnosis claim for prostate cancer\n* Had documented secondary metastasis code on or after the initial prostate cancer diagnosis\n* Had initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 90 days prior to the metastasis date or on or after the metastasis date. The initiation date of the earliest novel hormonal therapy will be defined as the index date\n* ≥18 years old on index date\n* Continuous enrollment for at least 365 days before index date\n* Evidence to be castration-sensitive:\n\n * No prior surgical castration any time prior to the index date or no medical castration with ≥8 weeks of continuous use within -90 to -365 days prior to the index date, OR\n * Diagnosis of hormone sensitive malignancy status within 90 days before the index date\n\nExclusion Criteria:\n\n* Evidence of castration-resistance prior to the index date\n\n * Received other prostate cancer treatment including NHT, non-steroidal anti-androgen (NSAA), chemotherapy, immunotherapy, radium 223, lutetium Lu 177 vipivotide tetraxetan, ketoconazole, or PARP inhibitor prior to the index date\n * Had diagnosis code indicating hormone resistance prior to the index date\n * A rise in prostate-specific antigen from the nadir by ≥2 ng/mL after castration\n* Had a prior history of other cancers (except non-melanoma skin cancer)\n* Participation in a clinical trial during the 30 days before the index date'}, 'identificationModule': {'nctId': 'NCT06151418', 'briefTitle': 'A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Novel Hormonal Therapy (NHT) for Treating Patients With Metastatic Castration-Sensitive Prostate Cancer (mCSPC): An Analysis of National Veterans Affairs Health Care Network Data', 'orgStudyIdInfo': {'id': 'C3431052'}, 'secondaryIdInfos': [{'id': 'NCT06151418', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Novel hormonal therapy cohort', 'description': 'Patients initiating novel hormonal therapy (abiraterone, apalutamide or enzalutamide) for mCSPC', 'interventionNames': ['Drug: Novel hormonal therapy']}], 'interventions': [{'name': 'Novel hormonal therapy', 'type': 'DRUG', 'otherNames': ['Abiraterone(Yonsa, Zytiga)', 'Apalutamide(Erleada)', 'Enzalutamide(Xtandi)'], 'description': 'As provided in real-world setting', 'armGroupLabels': ['Novel hormonal therapy cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Inc', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}