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Comprehensive Evaluation of the Regional Saturated Prostate Biopsy Scheme under mpMRI Technique

Comparison of Regional Saturation Prostate Biopsy and Targeted Biopsy as an Initial Prostate Cancer Diagnostic Strategy in Men With PI-RADS >=3: A Perspective, Randomized, and Non-Inferiority Clinical Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100053963
Enrollment
Unknown
Registered
2021-12-04
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

Prostate Cancer

Interventions

Group 1:Regional Saturation Prostate Biopsy
Group 2:Targeted Biopsy

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Male patients, aged 40 to 85 years; 2. PSA > 10 ng/ml, or PSA 4-10 ng/ml and f/T = 3; 4. Patients without previous biopsy; 5. The patients voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who want to withdraw for any reason during the study; 2. Patients who are contraindicated or unable to perform mpMRI; 3. Patients who cannot undergo perineal prostate puncture.

Design outcomes

Primary

MeasureTime frame
prostate cancer detection;—

Countries

China

Contacts

Public ContactJiang Xingkang

The Second Hospital of Tianjin Medical University

jiangx@tmu.edu.cn+86 18522535257

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026