Sequential bpMRI for Suspicious Prostate Lesions (SEQ-bpMRI)

Peking University

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Diagnostic Test: PSA test; Diagnostic Test: Bi parametric MRI

Study type: Observational

Funder types: Other

Identifiers

NCT07332832

2025R0590

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

1,000 participants in 1 patient group

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. 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).

Treatment:

Diagnostic Test: Bi parametric MRI

Diagnostic Test: PSA test