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Transperineal Versus Transrectal Cognitive Fusion Prostate Biopsy

NCT07710807 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-07-17

No results posted yet for this study

Summary

This prospective randomized controlled trial aims to compare transperineal and transrectal cognitive fusion prostate biopsy techniques in patients with suspicious prostate lesions detected by multiparametric magnetic resonance imaging (mpMRI).

Patients aged 50-75 years with PI-RADS 3-5 lesions on mpMRI and an indication for prostate biopsy will be randomly assigned in a 1:1 ratio to undergo either transperineal cognitive fusion prostate biopsy or transrectal cognitive fusion prostate biopsy.

The primary objective of this study is to evaluate whether transperineal cognitive fusion biopsy is non-inferior to transrectal cognitive fusion biopsy in detecting clinically significant prostate cancer (csPCa). Secondary objectives include comparison of overall prostate cancer detection rates, detection of Gleason Grade Group ≥2 prostate cancer, biopsy-related infectious complications, other procedure-related complications, pain scores, and procedure duration.

A total of 280 participants will be enrolled. Pathological evaluation will be performed after biopsy, and clinical outcomes and complications will be assessed during follow-up.

Conditions

Interventions

PROCEDURE

Transrectal Cognitive Fusion Prostate Biopsy

Cognitive fusion targeted prostate biopsy performed through the transrectal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy.

PROCEDURE

Transperineal Cognitive Fusion Prostate Biopsy

Cognitive fusion targeted prostate biopsy performed through the transperineal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy.

Sponsors & Collaborators

  • Ankara Etlik City Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07710807 on ClinicalTrials.gov