Cognitive and Fusion Prostatic Biopsy (CTB-FTB)

January 1, 2026 updated by: Mahmoud Ahmed Mohammed, Menoufia University

Cognitive Versus Image Guided Fusion Transrectal Prostatic Biopsy for the Detection of Prostate Cancer

The goal of this study is to compare two different prostate biopsy techniques used to detect prostate cancer. These techniques are cognitive-targeted biopsy (CTB) and magnetic resonance imaging-ultrasound fusion-targeted transrectal biopsy (FTB). Both methods aim to improve the accuracy of prostate cancer detection by targeting suspicious areas identified on prostate imaging. This study will compare how accurately each technique detects prostate cancer, the pathological findings obtained from each biopsy method, and how operator performance may influence the procedure. The information gained from this study may help improve prostate cancer diagnosis and guide future biopsy practices.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be conducted in the urology department, Menoufia University, and will include biopsy-naïve patients with clinical suspicion of prostate cancer. Suspicion will be based on abnormal digital rectal examination (DRE) findings and prostate-specific antigen (PSA) levels between 4 and 20 nanograms per milliliter (ng/mL).

All eligible patients will undergo multiparametric magnetic resonance imaging (mpMRI) of the prostate using a 1.5-Tesla scanner. Imaging will be interpreted by a single experienced radiologist. Only patients with lesions scored as Prostate Imaging-Reporting and Data System (PI-RADS) category 4 or 5 will be included in the study.

Participants who meet the inclusion criteria will undergo both cognitive-targeted biopsy (CTB) and magnetic resonance imaging-ultrasound fusion-targeted biopsy (FTB) during the same biopsy session. Biopsies will be performed under local or regional anesthesia using the BK3000 ultrasound system.

The study will assess predefined procedural and pathological parameters, including histopathological findings (presence or absence of malignancy and International Society of Urological Pathology [ISUP] grade group), lesion location by prostate zone and orientation, serum prostate-specific antigen and prostate-specific antigen density, lesion length, and procedure duration. Procedures will be performed by two operators (surgeon 1 and surgeon 2) according to the study protocol.

No results are reported in this section. Study outcomes will be entered in the results section after study completion.

Study Type

Interventional

Enrollment (Estimated)

80

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

Study Locations

  • Egypt
      • Shibīn al Kawm, Egypt
        • Not yet recruiting
        • Menoufia university hospital urology department
        • Contact:
      • Shibīn al Kawm, Egypt
        • Recruiting
        • Menoufia university hospital urology department

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Biopsy-naïve patients

Prostate-specific antigen level between 4 and 20 ng/mL

Multiparametric Magnetic Resonance Imaging Prostate Imaging-Reporting and Data System score 4 or 5

Exclusion Criteria:

Prior prostate biopsy

Prostate-specific Antigen level outside the specified range

Contraindication to Magnetic Resonance Imaging

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: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequential cognitive-targeted biopsy followed by fusion-targeted biopsy
Participants will undergo a cognitive-targeted prostate biopsy followed immediately by a fusion-targeted prostate biopsy during the same session. Each participant will receive both biopsy techniques sequentially, allowing within-subject comparison. Participants will be assigned to one of two surgeons using a blinded randomization process; however, all participants will receive the same intervention protocol.
Procedure: Cognitive-targeted prostate biopsy
Participants will undergo a cognitive-targeted prostate biopsy followed immediately by a fusion-targeted prostate biopsy during the same session.
Other Names:
  • Fusion-targeted prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate Cancer Detection Rate Assessed by Histopathological Examination
Time Frame: During the biopsy session
Detection of prostate cancer based on histopathological examination of biopsy core specimens obtained using cognitive-targeted biopsy and fusion-targeted biopsy. This outcome is reported as the presence or absence of prostate cancer and is not reported as a numerical score on a scale.
During the biopsy session
Clinically Significant Prostate Cancer Detection Rate Defined by International Society of Urological Pathology Grade Group
Time Frame: During the biopsy session
Detection of clinically significant prostate cancer based on histopathological evaluation of biopsy specimens obtained using each biopsy technique. Clinically significant prostate cancer is defined using the International Society of Urological Pathology (ISUP) Grade Group classification, which ranges from Grade Group 1 (least aggressive) to Grade Group 5 (most aggressive). Clinically significant disease is defined as ISUP Grade Group 2 or higher. Higher ISUP grade groups indicate a worse pathological outcome.
During the biopsy session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biopsy Procedure Time Measured in Minutes
Time Frame: During the procedure
Duration of each biopsy technique, measured in minutes from insertion of the ultrasound probe to completion of tissue sampling for cognitive-targeted biopsy and fusion-targeted biopsy. This outcome is a direct time measurement and not a scale-based score.
During the procedure
Target Lesion Length Measured on Multiparametric Magnetic Resonance Imaging
Time Frame: Before the biopsy procedure
Maximum lesion length measured in millimeters on pre-biopsy multiparametric magnetic resonance imaging. This outcome is a direct physical measurement and not a score on a scale.
Before the biopsy procedure
Procedural Metrics According to Surgeon Assignment
Time Frame: During the biopsy procedure
Assessment of procedural parameters, including procedure duration, according to surgeon assignment. These outcomes are not reported as scale-based scores.
During the biopsy procedure

Collaborators and Investigators

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

Sponsor

Menoufia University

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)

December 28, 2025

Primary Completion (Estimated)

May 5, 2026

Study Completion (Estimated)

August 5, 2026

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

December 13, 2025

First Posted (Estimated)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

January 1, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UROL 22

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.

Clinical Trials on Prostate Cancer

Clinical Trials on Cognitive-targeted prostate biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe