Transperineal Versus Transrectal Cognitive Fusion Prostate Biopsy

NCT07710807 | Recruiting

• 2 other identifiers: AEŞH-EK-2026-114ANKARA ETLIK CITY HOSPİTAL
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer; Clinically Significant Prostate Cancer; Cognitive Fusion

Keywords

prostate biopsy; Transperineal biopsy; Transrectal biopsy; Multiparametric magnetic resonance imaging; Prostate cancer detection

Outcome Measures

Primary Outcomes (1)

• Clinically significant prostate cancer detection rate

  Comparison of clinically significant prostate cancer (csPCa) detection rates between transperineal and transrectal cognitive fusion prostate biopsy techniques. Clinically significant prostate cancer is defined as Gleason Grade Group ≥2 (ISUP Grade Group ≥2) prostate cancer.

  Within 4 weeks after biopsy (after final pathological evaluation)

Secondary Outcomes (5)

• Overall prostate cancer detection rate

  Within 4 weeks after biopsy (after final pathological evaluation)

• Post-biopsy infectious complications

  Within 30 days after biopsy

• Post-biopsy procedure-related complications

  Within 30 days after biopsy

• Pain score after biopsy procedure

  Immediately after biopsy procedure

• Procedure duration

  During biopsy procedure

Study Arms (2)

Transrectal Cognitive Fusion Prostate Biopsy

ACTIVE COMPARATOR

Participants randomized to this arm will undergo transrectal cognitive fusion targeted prostate biopsy combined with systematic prostate biopsy according to the institutional protocol.

Procedure: Transrectal Cognitive Fusion Prostate Biopsy

Transperineal Cognitive Fusion Prostate Biopsy

EXPERIMENTAL

Participants randomized to this arm will undergo transperineal cognitive fusion targeted prostate biopsy combined with systematic prostate biopsy according to the institutional protocol.

Procedure: Transperineal Cognitive Fusion Prostate Biopsy

Interventions

Transperineal Cognitive Fusion Prostate Biopsy PROCEDURE

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

Transperineal Cognitive Fusion Prostate Biopsy

Transrectal Cognitive Fusion Prostate Biopsy PROCEDURE

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

Transrectal Cognitive Fusion Prostate Biopsy

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients aged 50-75 years.
• Patients with PI-RADS 3, 4, or 5 lesions detected on multiparametric prostate magnetic resonance imaging (mpMRI).
• Patients with an indication for prostate biopsy.
• Patients who are willing to participate and provide informed consent.

You may not qualify if:

• Previous diagnosis of prostate cancer.
• Active urinary tract infection.
• Coagulopathy or bleeding disorders preventing prostate biopsy.
• Absence of multiparametric prostate MRI evaluation.
• No indication for prostate biopsy.

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

MUHAMMED Y AYDIN, Doctor

CONTACT

+90 554 838 4510; mysfa63@gmail.com

ALPER G GÖK, PROFESSOR DOCTOR

CONTACT

+90 532 603 1181; alper_gok@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Pathologists evaluating biopsy specimens will be blinded to the biopsy technique. Participants, care providers, and investigators performing the biopsy procedure will not be blinded due to the nature of the intervention.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTOR

Model Details: Participants will be randomized in a 1:1 ratio to receive either transrectal cognitive fusion prostate biopsy or transperineal cognitive fusion prostate biopsy. Randomization will be stratified according to PI-RADS category (3, 4, or 5) and age group (\<60 or ≥60 years).

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)