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NCT07332832Not yet recruiting

Sequential bpMRI for Suspicious Prostate Lesions

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

Source: ClinicalTrials.gov · Last updated 18 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
30 Dec 2025
Start date
Feb 2026
Primary completion date
Dec 2028
Lead sponsor
Peking University First Hospital
NCT number
NCT07332832

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From Feb 2026 to the primary completion date, Dec 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current use of 5-alpha reductase inhibitors (5-ARIs).

Other illness

  • Pathologically confirmed diagnosis of clinically significant prostate cancer (csPCa).
  • 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).

Other

  • Contraindications to prostate biopsy or inability to tolerate the procedure.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 85 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.