Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bi parametric MRI | Diagnostic Test | — | UNRESOLVED |
| PSA test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- MRI follow-up cohort of patients with clinically suspected prostate cancer
- description
- 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).
- interventionNames
- Diagnostic Test: PSA test
- Diagnostic Test: Bi parametric MRI
Primary outcomes (1)
- measure
- csPCa detection rate
- timeFrame
- From enrollment to the end of follow up at 24 weeks
- description
- Clinically significant prostate cancer detection rates across different radiological changes (progression, stability, and regression)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available