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Not yet recruiting NCT07332832

Sequential bpMRI for Suspicious Prostate Lesions

— Observational Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PSA test, Bi parametric MRI.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: 18 years — 85 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Diagnostic test PSA test
    Blood PSA test every 6 months
  • Diagnostic test Bi parametric MRI
    Bi parametric MRI examination every year.

Primary outcome measures

  • csPCa detection rate [Time frame: From enrollment to the end of follow up at 24 weeks]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07332832 · 2025R0590

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗