Sequential bpMRI for Suspicious Prostate Lesions

NCT ID: NCT07332832

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2029-05-31

Brief Summary

This study aims to establish a prospective exploratory cohort and database to observe the dynamic evolution of bi-parametric MRI (bpMRI). We intend to investigate 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, we 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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MRI follow-up cohort of patients with clinically suspected prostate cancer

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.

Biopsy Decision-Making:

Triggered 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.

Endpoint 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).

PSA test

Intervention Type: DIAGNOSTIC_TEST

Blood PSA test every 6 months

Bi parametric MRI

Intervention Type: DIAGNOSTIC_TEST

Bi parametric MRI examination every year.

Interventions

PSA test

Blood PSA test every 6 months

Intervention Type: DIAGNOSTIC_TEST

Bi parametric MRI

Bi parametric MRI examination every year.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Aged 18 to 85 years.
• Total PSA (tPSA) level ranging from 3 ng/ml to 20 ng/ml (inclusive).
• Underwent prostate MRI at the study institution with complete imaging sequences.
• Capable of providing written informed consent.
• 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).
• Biopsy-naïve patients with PI-RADS 2, or PI-RADS 3 combined with PSAD < 0.2 ng/ml².

Exclusion Criteria

• Pathologically confirmed diagnosis of clinically significant prostate cancer (csPCa).
• Contraindications to prostate biopsy or inability to tolerate the procedure.
• Current use of 5-alpha reductase inhibitors (5-ARIs).
• 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.
• Contraindications to bi-parametric MRI (bpMRI) (e.g., severe claustrophobia, cardiac pacemakers).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai East Hospital of Tongji University

OTHER

Sponsor Role: collaborator

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yi Liu, Medical Doctor

Role: CONTACT

liuyipkuhsc@163.com

+86 13611035261

Other Identifiers

2025R0590

Identifier Type: -

Identifier Source: org_study_id