NCT07332832

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
38mo left

Started Feb 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Feb 2026May 2029

First Submitted

Initial submission to the registry

December 30, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

February 18, 2026

Status Verified

December 1, 2025

Enrollment Period

2.9 years

First QC Date

December 30, 2025

Last Update Submit

February 13, 2026

Conditions

Prostate Cancer

Keywords

prostate cancerMagnetic resonance imagingFollow up

Outcome Measures

Primary Outcomes (1)

  • csPCa detection rate

    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

Study Arms (1)

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 testDiagnostic Test: Bi parametric MRI

Interventions

PSA testDIAGNOSTIC_TEST

Blood PSA test every 6 months

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

Bi parametric MRI examination every year.

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

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Prostate biopsy tissue for pathological diagnosis

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Yi Liu, Medical Doctor

CONTACT

+86 13611035261liuyipkuhsc@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2025

First Posted

January 12, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

May 31, 2029

Last Updated

February 18, 2026

Record last verified: 2025-12