Sequential bpMRI for Suspicious Prostate Lesions

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07332832

Acronym

SEQ-bpMRI

Enrollment

1000

Registered

2026-01-12

Start date

2026-02-01

Completion date

2029-05-31

Last updated

2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer, Magnetic resonance imaging, Follow up

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.

Interventions

DIAGNOSTIC_TESTPSA test

Blood PSA test every 6 months

DIAGNOSTIC_TESTBi parametric MRI

Bi parametric MRI examination every year.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 85 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
csPCa detection rate	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)

Contacts

CONTACTYi Liu, Medical Doctor

liuyipkuhsc@163.com+86 13611035261

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026