Comparing cognitive targeting and MRI–ultrasound fusion targeting during prostate biopsy
Cognitive Versus Image Guided Fusion Transrectal Prostatic Biopsy for the Detection of Prostate Cancer
NA · Menoufia University · NCT07306741
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Sex | Male |
| Sponsor | Menoufia University (other) |
| Locations | 2 sites (Shibīn al Kawm and 1 other locations) |
| Trial ID | NCT07306741 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shibīn al Kawm and 1 other locations
- Menoufia university hospital urology department — Shibīn al Kawm, Egypt (NOT_YET_RECRUITING)
- Menoufia university hospital urology department — Shibīn al Kawm, Egypt (RECRUITING)
Study contacts
- Study coordinator: Mahmoud A Wahbah, MASTER
- Email: mwahbah4@gmail.com
- Phone: 00201015684868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Cognitive-Targeted Biopsy, Magnetic Resonance Imaging-Ultrasound Fusion Biopsy, Multiparametric Magnetic Resonance Imaging, Transrectal Prostate Biopsy, Prostate Cancer Detection, Diagnostic Accuracy