Sequential bpMRI for Suspicious Prostate Lesions (SEQ-bpMRI)

February 13, 2026 updated by: Peking University First Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with clinical suspicion of prostate cancer presenting to Peking University First Hospital and Shanghai East Hospital (Affiliated to Tongji University)

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Diagnostic test: PSA test
Blood PSA test every 6 months
Diagnostic test: Bi parametric MRI
Bi parametric MRI examination every year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From enrollment to the end of follow up at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Shanghai East Hospital of Tongji University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

May 31, 2029

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Actual)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025R0590

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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