Home › Trials › NCT07306741
Clinical trial Recruiting at 1 site Interventional Men only

Comparing cognitive targeting and MRI–ultrasound fusion targeting during prostate biopsy

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

Run by Menoufia University · NCT07306741 · Data updated 2026-11-12

This trial will test whether cognitive-targeted biopsy or MRI–ultrasound fusion-targeted transrectal biopsy better finds prostate cancer in men who are biopsy‑naïve with PSA 4–20 ng/mL and a PI‑RADS 4–5 lesion on mpMRI.

Quick facts

Study typeInterventional
SexMen only
Enrollment80 (estimated)
SponsorMenoufia University
Academic / other
Locations2 sites (Shibīn al Kawm and 1 other locations)
StatusRecruiting
StartedDecember 28, 2025
Main results expectedMay 5, 2026
Study endsAugust 5, 2026
Registry record updatedJanuary 5, 2026
Trial IDNCT07306741 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men who have never had a prostate biopsy, have PSA between 4 and 20 ng/mL, an abnormal DRE, and a PI‑RADS 4 or 5 lesion on mpMRI are the ideal candidates.

Probably not a fit

Men with a prior prostate biopsy, PSA outside the 4–20 ng/mL range, contraindications to MRI, or PI‑RADS scores below 4 are unlikely to benefit or to be eligible for this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Menoufia University will enroll biopsy‑naïve men with clinical suspicion of prostate cancer based on abnormal DRE and PSA 4–20 ng/mL who have a PI‑RADS 4 or 5 lesion on 1.5‑Tesla mpMRI read by a single experienced radiologist. Each participant will undergo both cognitive-targeted biopsy (CTB) and MRI–ultrasound fusion-targeted biopsy (FTB) in the same transrectal biopsy session using a BK3000 ultrasound system under local or regional anesthesia. Two operators will perform procedures per protocol and the study will record procedural and pathological parameters including cancer detection, ISUP grade group, lesion location, PSA and PSA density, lesion length, procedure duration, and operator performance. The comparison aims to determine which targeting method more accurately detects clinically significant prostate cancer and to inform future biopsy practice.

Why it matters

Potential benefit: If successful, the study could help clinicians choose the biopsy method that more accurately detects clinically significant prostate cancer, reducing missed diagnoses and unnecessary repeat procedures.

How similar studies have gone: MRI‑targeted biopsy approaches have improved detection of clinically significant prostate cancer compared with systematic biopsy, but head‑to‑head comparisons between cognitive and fusion targeting have produced mixed results and remain under active study.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Prostate Cancer 1464Menoufia University 33
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.