Sequential bpMRI for Suspicious Prostate Lesions

Evaluation of Suspicious Prostate Lesions Via Sequential Bi-parametric MRI: A Multi-center Prospective Cohort Study

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.

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).