Exploration of the Application of Perilesional Biopsy of Prostate Cancer in Patients with Suspected Prostate Cancer and Prostate-Specific Antigen >= 20 ng/mL: A Comparative Analysis between Regional Saturation Biopsy and Targeted Biopsy

Investigation of the Application of Regional Saturation Biopsy and Targeted Biopsy in Patients with Suspected Prostate Cancer and Prostate-Specific Antigen >= 20 ng/mL

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500100719

Enrollment

Unknown

Registered

2025-04-14

Start date

2025-04-20

Completion date

Unknown

Last updated

2025-04-21

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

Conditions

Prostate Cancer

Interventions

Gold Standard:Targeted prostate biopsy + systematic prostate biopsy

Index test:Detection rate of clinically significant prostate cancer

Eligibility

Sex/Gender

Male

Age

18 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1. Male patients aged 18-95 years; 2. Initial serum total PSA level >=20 ng/mL; 3. PI-RADS score >=3 confirmed by multiparametric MRI evaluation; 4. No history of prostate biopsy; 5. Voluntarily provided written informed consent.

Exclusion criteria

Exclusion criteria: 1. Refusal to sign informed consent; 2. Voluntary withdrawal from the study during the research period; 3. Contraindications to multiparametric MRI (mpMRI) or inability to complete the examination; 4. Anatomical contraindications (e.g., perineal structural abnormalities) precluding transperineal prostate biopsy.

Design outcomes

Primary

Measure	Time frame
Detection rate of clinically significant prostate cancer;	—

Secondary

Measure	Time frame
Detection rate of prostate cancer;Detection rate of clinically insignificant prostate cancer;adverse reaction;	—

Countries

China

Contacts

Public ContactXingkang Jiang

The Second Hosptial of Tianjin Medical University

jiangx@tmu.edu.cn+86 185 2253 5257

Outcome results

None listed

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