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A comparative study of intraoperative frozen section biopsy and transperineal targeted prostate biopsy for the diagnosis of prostate cancer in patients with PI-RADS 4-5

Comparative study of intraoperative rapid frozen prostate biopsy and perineal targeted prostate biopsy for the diagnosis of prostate cancer in patients with PI-RADS4-5 scores

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092705
Enrollment
Unknown
Registered
2024-11-21
Start date
2024-09-30
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

prostate cancer

Interventions

Frozen section group:None
Targeted biopsy group:None

Sponsors

Northern Jiangsu People's Hospital Affiliated to Yangzhou University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 89 Years

Inclusion criteria

Inclusion criteria: (1) The prostate imaging report before prostate puncture shows suspicious lesions with a PI-RADS score of 4-5; (2) Having complete clinical basic information. (3) Perform prostate frozen biopsy surgery or transperineal prostate system fusion targeted puncture surgery.

Exclusion criteria

Exclusion criteria: (1) Receiving treatment related to prostate malignant tumors before puncture (2) failed to cooperate in completing the prostate puncture surgery; (3) Contraindications for biopsy include infection, coagulation dysfunction, hypertension emergency, severe heart failure, etc; (4) MRI did not indicate prostate mass lesions.

Design outcomes

Primary

MeasureTime frame
Time for Pathology Report;Positive rate;Pathological upgrade status;Clinically significant prostate cancer;false negative rate;Gleason score;PI-RADS score;PSA density;

Secondary

MeasureTime frame
prostate volume;age;PSA;

Countries

China

Contacts

Public ContactDing Xuefei

Department of Urology Surgery, Northern Jiangsu People's Hospital Affiliated to Yangzhou University

xuefeid@126.com+86 180 5106 1234

Outcome results

None listed

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