Sequential bpMRI for Suspicious Prostate Lesions

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–85 year

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PSA test

Diagnostic Test

Blood PSA test every 6 months

Bi parametric MRI

Diagnostic Test

Bi parametric MRI examination every year.

Primary outcomes

csPCa detection rate

Time frame: From enrollment to the end of follow up at 24 weeks

Clinically significant prostate cancer detection rates across different radiological changes (progression, stability, and regression)

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Liu, Medical Doctor

CONTACT

[email protected]

+86 13611035261

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

Shanghai East Hospital of Tongji University

Registry information

Official study title

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

Acronym: SEQ-bpMRI

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Jan 12, 2026
Registry last updated: Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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