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A study on the diagnostic efficacy of prostate-targeted biopsy plus biopsy around the main lesion: A prospective paired, non-inferiority trial clinical study

A study on the diagnostic efficacy of prostate-targeted biopsy plus biopsy around the main lesion: A prospective paired, non-inferiority trial clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124005
Enrollment
Unknown
Registered
2026-05-06
Start date
2024-12-01
Completion date
Unknown
Last updated
2026-05-11

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:Prostate targeted puncture + systematic puncture
Index test:Prostate targeted puncture + puncture around the main lesion

Sponsors

Northern Jiangsu People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Prostate-specific antigen (PSA) > 4 ng/ml; 2. The PI-RADS (Prostate Imaging Reporting and Data System) score of the lesion on prostate MRI is >= 4 points; 3. Prostate biopsy has been performed;

Exclusion criteria

Exclusion criteria: 1. Prostate biopsy contraindications; 2. Previous prostate biopsy; 3. Previous history of androgen deprivation therapy (ADT), pelvic radiotherapy, etc.; 4. Previous history of transurethral prostate resection (TURP).

Design outcomes

Primary

MeasureTime frame
Confidence interval of the difference in clinically significant prostate cancer (csPCa) detection rate between targeted plus perilesional biopsy and targeted plus systematic biopsy;—

Secondary

MeasureTime frame
Additional csPCa detection rate outside the index lesion by biopsy;Pathological upgrading rate after surgery;—

Countries

China

Contacts

Public ContactDing Xuefei

Northern Jiangsu People's Hospital

mn103ding@163.com+86 180 5106 1234

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026