Ignite Creation Date:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2025-12-26 @ 11:45 AM
Study NCT ID:
NCT06326216
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer
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': 'With permission of participant, blood and urine samples may be retained for use in future research.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy', 'timeFrame': 'Pre-surgery; once post-surgery, 6 weeks to 6 months after surgery (likely collected during routine visits); annual blood collection (optional)', 'description': 'Levels of prostate cancer-derived EVs will be assessed using blood and urine samples'}, {'measure': 'Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls', 'timeFrame': 'Baseline', 'description': 'Levels of prostate cancer-derived EVs will be assess using blood and urine samples'}, {'measure': 'Correlation between prostate specific antigen (PSA) levels and prostate cancer-derived EVs', 'timeFrame': 'Baseline', 'description': 'PSA levels and EVs will be determined from blood and urine samples and will be assessed by correlation analysis.'}, {'measure': 'Prostate cancer-derived EV levels', 'timeFrame': 'Baseline', 'description': 'Prostate cancer-derived EV levels will be determined from blood and urine samples and will be assessed by comparative analysis between prostate cancer patients and female patients (negative controls).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study is being done to determine whether levels of prostate cancer derived extracellular vesicles from blood and urine specimens correlate with response to primary local treatment (surgery) in prostate cancer.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. Determine the levels of prostate cancer-derived extracellular vesicles pre- and post-RP.\n\nII. Determine the correlation between levels of prostate cancer-derived extracellular vesicles and PSA.\n\nOUTLINE: This is an observational study. Participants are assigned to 1 of 2 cohorts.\n\nCOHORT I (RADICAL PROSTATECTOMY): Prostate cancer patients undergo blood and urine sample collection on study. Patients' medical records are also reviewed.\n\nCOHORT II (NEOADJUVANT): Prostate cancer patients undergo blood and urine sample collection throughout the study. Patients' medical records are also reviewed.\n\nCOHORT III (NEGATIVE CONTROLS): Female urology clinic patients and female volunteers undergo blood and urine sample collection on study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with prostate cancer and undergoing prostatectomy as a local treatment and female patients seen in the Urology Clinic or female research volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PROSTATE CANCER PATIENTS:\n\n * Age 18+\n * Able to give informed consent\n * Patients with prostate cancer\n * Patients treated with primary prostatectomy\n\n * The focus will be on high-risk patients with at least one of either criterion:\n * PSA \\>= 20 ng/ml\n * AND/OR Gleason \\>= 8\n * AND/OR clinical stage \\>= T3\n* FEMALE CONTROL PATIENTS:\n\n * Age 18+\n * Able to give informed consent\n\nExclusion Criteria:\n\n* PROSTATE CANCER PATIENTS:\n\n * Unable or unwilling to provide informed consent\n * Metastatic prostate cancer - defined evidence of metastatic disease on pre-procedural testing\n* FEMALE CONTROL PATIENTS:\n\n * Unable or unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06326216', 'briefTitle': 'Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer', 'orgStudyIdInfo': {'id': '19-011292'}, 'secondaryIdInfos': [{'id': 'NCI-2023-05221', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '19-011292', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (Cohort I)', 'description': "Prostate cancer patients undergo blood and urine sample collection on study. Patients' medical records are also reviewed.", 'interventionNames': ['Other: Non-Interventional Study']}, {'label': 'Observational (Cohort III)', 'description': 'Female urology clinic patients and female volunteers undergo blood and urine sample collection on study.', 'interventionNames': ['Other: Non-Interventional Study']}, {'label': 'Observational (Cohort II)', 'description': "Prostate cancer patients undergo blood and urine sample collection throughout the study. Patients' medical records are also reviewed."}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'description': 'Non-interventional study', 'armGroupLabels': ['Observational (Cohort I)', 'Observational (Cohort III)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Eugene D. Kwon, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}