Transperineal Versus Transrectal Cognitive Fusion Prostate Biopsy (PROCOG)

July 14, 2026 updated by: Muhammed Yusuf Aydın, Ankara Etlik City Hospital

Comparison of Transperineal and Transrectal Cognitive Fusion Prostate Biopsy for the Detection of Clinically Significant Prostate Cancer in Patients With mpMRI-Detected Suspicious Lesions: A Prospective Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prostate cancer is one of the most common malignancies among men. Multiparametric magnetic resonance imaging (mpMRI) has become an important tool for prostate cancer detection and risk stratification, particularly with the use of the Prostate Imaging Reporting and Data System (PI-RADS). Patients with PI-RADS 3-5 lesions are frequently considered candidates for targeted prostate biopsy.

Transrectal ultrasound-guided prostate biopsy has traditionally been the standard biopsy approach. However, the transrectal route may carry a risk of infectious complications due to passage through rectal mucosa and exposure to rectal flora. Transperineal prostate biopsy has gained increasing interest because it avoids transgression of the rectal mucosa and may reduce infectious complications.

Cognitive fusion biopsy is an MRI-targeted biopsy technique in which mpMRI findings are mentally correlated with real-time ultrasound images by the operator. This technique provides an accessible alternative to software-based fusion systems and can achieve accurate targeted sampling when performed by experienced clinicians.

The aim of this study is to prospectively compare transperineal and transrectal cognitive fusion prostate biopsy techniques regarding diagnostic performance and safety outcomes in patients with PI-RADS 3-5 lesions detected on mpMRI.

Eligible participants aged 50-75 years with biopsy indications will be randomized using a computer-generated stratified block randomization method. Randomization will be stratified according to PI-RADS category (3, 4, or 5) and age group (<60 years and ≥60 years).

Participants will undergo either transperineal or transrectal cognitive fusion prostate biopsy according to their assigned study group. Systematic biopsy cores and targeted biopsy cores will be obtained according to the institutional protocol.

The primary endpoint is the detection rate of clinically significant prostate cancer, defined as Gleason Grade Group ≥2 (ISUP Grade Group ≥2) prostate cancer. The primary analysis will evaluate non-inferiority of transperineal biopsy compared with transrectal biopsy.

Secondary endpoints include overall prostate cancer detection rate, Gleason Grade Group ≥2 cancer detection, infectious complications (fever, urinary infection, prostatitis, sepsis), procedure-related complications (hematuria, hematospermia, urinary retention), pain assessed by visual analog scale (VAS), and procedure duration.

Participants will be followed for 30 days after biopsy for assessment of adverse events and complications.

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: MUHAMMED Y AYDIN, Doctor
  • Phone Number: +90 +90 554 838 4510
  • Email: mysfa63@gmail.com

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06170
        • Recruiting
        • Ankara Etlik City Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transrectal Cognitive Fusion Prostate Biopsy
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
Cognitive fusion targeted prostate biopsy performed through the transrectal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy.
Experimental: Transperineal Cognitive Fusion Prostate Biopsy
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
Cognitive fusion targeted prostate biopsy performed through the transperineal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically significant prostate cancer detection rate
Time Frame: Within 4 weeks after biopsy (after final pathological evaluation)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall prostate cancer detection rate
Time Frame: Within 4 weeks after biopsy (after final pathological evaluation)
Comparison of overall prostate cancer detection rates between transperineal and transrectal cognitive fusion prostate biopsy techniques
Within 4 weeks after biopsy (after final pathological evaluation)
Post-biopsy infectious complications
Time Frame: Within 30 days after biopsy
Assessment and comparison of infectious complications including fever, urinary infection, prostatitis, and sepsis after prostate biopsy.
Within 30 days after biopsy
Post-biopsy procedure-related complications
Time Frame: Within 30 days after biopsy
Assessment and comparison of procedure-related complications including hematuria, hematospermia, urethral bleeding, and urinary retention.
Within 30 days after biopsy
Pain score after biopsy procedure
Time Frame: Immediately after biopsy procedure
Assessment of patient-reported pain using the Visual Analog Scale (VAS) after biopsy.
Immediately after biopsy procedure
Procedure duration
Time Frame: During biopsy procedure
Comparison of procedure duration between transperineal and transrectal cognitive fusion prostate biopsy techniques.
During biopsy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

July 14, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEŞH-EK-2026-114
  • ANKARA ETLIK CITY HOSPİTAL (Other Identifier: ANKARA ETLIK CITY HOSPİTAL)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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