Cognitive and Fusion Prostatic Biopsy

NCT07306741 | Recruiting DMC

• 1 other identifier: UROL 22
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Cognitive-Targeted Biopsy; Magnetic Resonance Imaging-Ultrasound Fusion Biopsy; Multiparametric Magnetic Resonance Imaging; Transrectal Prostate Biopsy; Prostate Cancer Detection; Diagnostic Accuracy

Outcome Measures

Primary Outcomes (2)

• Prostate Cancer Detection Rate Assessed by Histopathological Examination

  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

  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 Outcomes (3)

• Biopsy Procedure Time Measured in Minutes

  During the procedure

• Target Lesion Length Measured on Multiparametric Magnetic Resonance Imaging

  Before the biopsy procedure

• Procedural Metrics According to Surgeon Assignment

  During the biopsy procedure

Study Arms (1)

Sequential cognitive-targeted biopsy followed by fusion-targeted biopsy

EXPERIMENTAL

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

Interventions

Cognitive-targeted prostate biopsy PROCEDURE

Participants will undergo a cognitive-targeted prostate biopsy followed immediately by a fusion-targeted prostate biopsy during the same session.

Also known as: Fusion-targeted prostate biopsy

Sequential cognitive-targeted biopsy followed by fusion-targeted biopsy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior prostate biopsy
• Prostate-specific Antigen level outside the specified range
• Contraindication to Magnetic Resonance Imaging

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (2)

Menoufia university hospital urology department

Shibīn al Kawm, Egypt

NOT YET RECRUITING

Menoufia university hospital urology department

Shibīn al Kawm, Egypt

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

Mahmoud A Wahbah, MASTER

CONTACT

00201015684868; mwahbah4@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT LECTURER

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 29, 2025
• Study Start: December 28, 2025
• Primary Completion: May 5, 2026
• Study Completion (Estimated): August 5, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)