Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-06 @ 8:55 AM
Study NCT ID:
NCT07332832
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2025-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sequential bpMRI for Suspicious Prostate Lesions
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Prostate biopsy tissue for pathological diagnosis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2025-12-30', 'studyFirstSubmitQcDate': '2025-12-30', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'csPCa detection rate', 'timeFrame': 'From enrollment to the end of follow up at 24 weeks', 'description': 'Clinically significant prostate cancer detection rates across different radiological changes (progression, stability, and regression)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'Magnetic resonance imaging', 'Follow up'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to establish a prospective exploratory cohort and database to observe the dynamic evolution of bi-parametric MRI (bpMRI). Investigators intend to study the clinical utility of sequential MRI combined with prostate biopsy in the diagnosis of prostate cancer. Specifically, by utilizing bpMRI findings and their dynamic changes to guide the timing of biopsies, investigators aim to avoid unnecessary procedures. Furthermore, the safety and efficacy of this strategy will be assessed through long-term follow-up, ultimately promoting the precision diagnosis and treatment of prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with clinical suspicion of prostate cancer presenting to Peking University First Hospital and Shanghai East Hospital (Affiliated to Tongji University)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 to 85 years.\n* Total PSA (tPSA) level ranging from 3 ng/ml to 20 ng/ml (inclusive).\n* Underwent prostate MRI at the study institution with complete imaging sequences.\n* Capable of providing written informed consent.\n* Patients with PI-RADS 4-5, or PI-RADS 3 combined with PSAD ≥ 0.2 ng/ml², who have undergone prostate biopsy with no diagnosis of clinically significant prostate cancer (csPCa).\n* Biopsy-naïve patients with PI-RADS 2, or PI-RADS 3 combined with PSAD \\< 0.2 ng/ml².\n\nExclusion Criteria:\n\n* Pathologically confirmed diagnosis of clinically significant prostate cancer (csPCa).\n* Contraindications to prostate biopsy or inability to tolerate the procedure.\n* Current use of 5-alpha reductase inhibitors (5-ARIs).\n* History of hip replacement, metallic hip arthroplasty, or extensive pelvic orthopedic surgery with metallic hardware, or presence of other implants that would degrade MRI image quality.\n* Contraindications to bi-parametric MRI (bpMRI) (e.g., severe claustrophobia, cardiac pacemakers).'}, 'identificationModule': {'nctId': 'NCT07332832', 'acronym': 'SEQ-bpMRI', 'briefTitle': 'Sequential bpMRI for Suspicious Prostate Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Evaluation of Suspicious Prostate Lesions Via Sequential Bi-parametric MRI: A Multi-center Prospective Cohort Study', 'orgStudyIdInfo': {'id': '2025R0590'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MRI follow-up cohort of patients with clinically suspected prostate cancer', 'description': 'Scheduled Follow-up: All enrolled patients will undergo a follow-up period of 24 months. Every 6 months: PSA testing, Digital Rectal Examination (DRE), and clinical assessment. At months 12 and 24: Repeat bi-parametric MRI (bpMRI) examinations.\n\nBiopsy Decision-Making:\n\nTriggered Biopsy: During the follow-up period (e.g., at month 12), a prostate biopsy will be recommended if the patient exhibits MRI progression to PI-RADS 4/5, or presents with PI-RADS 3 combined with a PSA density (PSAD) \\> 0.2 ng/ml².\n\nEndpoint Biopsy: To ensure study rigor and safety, patients who have not undergone biopsy due to radiological progression during the 24-month follow-up will be advised to undergo a confirmatory biopsy at the study endpoint (month 24). This aims to maximally exclude the missed diagnosis of clinically significant prostate cancer (csPCa).', 'interventionNames': ['Diagnostic Test: PSA test', 'Diagnostic Test: Bi parametric MRI']}], 'interventions': [{'name': 'PSA test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood PSA test every 6 months', 'armGroupLabels': ['MRI follow-up cohort of patients with clinically suspected prostate cancer']}, {'name': 'Bi parametric MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Bi parametric MRI examination every year.', 'armGroupLabels': ['MRI follow-up cohort of patients with clinically suspected prostate cancer']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yi Liu, Medical Doctor', 'role': 'CONTACT', 'email': 'liuyipkuhsc@163.com', 'phone': '+86 13611035261'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai East Hospital of Tongji University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}