Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-08 @ 5:55 AM
Study NCT ID:
NCT06067295
Status:
RECRUITING
Last Update Posted:
2025-08-29
First Post:
2023-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Advanced Prostate Cancer Cohort (LAPCC)
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue, blood, and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-02-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2023-09-27', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collection of biological specimens and clinical data for future research related to prostate cancer.', 'timeFrame': 'Up to 5 years', 'description': 'The objective of this study is to create a biorepository of biospecimen and clinical data. There is no primary clinical outcome for this study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study examines information from patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). By collecting biological samples (like blood, urine, and tissue), and health information (such as treatment, diet, and quality of life) researchers hope to learn more about prostate cancer and ways to improve outcomes in the future.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To create an annotated biorepository with prospectively collected blood and urine samples from men with advanced prostate cancer.\n\nOUTLINE: This is an observational study.\n\nPatients undergo blood and urine sample collection, complete surveys, and have their medical records reviewed on study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult men diagnosed with advanced (metastatic) prostate cancer at Norris Comprehensive Cancer Center and Los Angeles General Medical Center with either metastatic castrate sensitive prostate cancer (mCSPC) or metastatic castration-resistant prostate cancer (mCRPC).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men of all racial and ethnic groups 18 years of age or older\n* Men with a diagnosis of advanced (metastatic) prostate cancer who are scheduled to begin a new systemic treatment (including first or subsequent lines of therapy)\n* Prior participation on clinical trials is allowed\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Any other malignancy, unless previously treated with curative intent and the subject has been disease free for 3 years or longer'}, 'identificationModule': {'nctId': 'NCT06067295', 'briefTitle': 'Longitudinal Advanced Prostate Cancer Cohort (LAPCC)', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Longitudinal Advanced Prostate Cancer Cohort (LAPCC)', 'orgStudyIdInfo': {'id': '4P-22-2'}, 'secondaryIdInfos': [{'id': 'NCI-2023-01434', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '4P-22-2', 'type': 'OTHER', 'domain': 'USC / Norris Comprehensive Cancer Center'}, {'id': 'P30CA014089', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014089', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients undergo blood and urine sample collection, complete surveys, and have their medical records reviewed on study.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'description': 'Non-interventional study', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cheryl Kefauver, RN', 'role': 'CONTACT', 'email': 'cheryl.kefauver@med.usc.edu', 'phone': '323-865-0459'}, {'name': 'Amir Goldkorn, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Los Angeles General Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cheryl Kefauver, RN', 'role': 'CONTACT', 'email': 'cheryl.kefauver@med.usc.edu', 'phone': '323-865-0459'}, {'name': 'Amir Goldkorn, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'USC / Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Cheryl Kefauver, RN', 'role': 'CONTACT', 'email': 'Cheryl.Kefauver@med.usc.edu', 'phone': '323-865-0459'}], 'overallOfficials': [{'name': 'Amir Goldkorn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}