Transperineal vs Transrectal Cognitive Fusion Biopsy for Prostate Cancer
Official title: 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
Run by Ankara Etlik City Hospital · NCT07710807 · Data updated 2026-11-12
This study tests whether a transperineal cognitive fusion biopsy works as well as the traditional transrectal approach for detecting clinically significant prostate cancer in men with suspicious mpMRI findings.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years to 75 Years |
| Sex | Men only |
| Enrollment | 280 (estimated) |
| Sponsor | Ankara Etlik City Hospital Government |
| Locations | 1 site (Ankara, Yenimahalle) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | March 31, 2027 |
| Registry record updated | July 17, 2026 |
| Trial ID | NCT07710807 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men aged 50-75 with PI-RADS 3-5 lesions on mpMRI and a clinical indication for prostate biopsy.
✕Probably not a fit
Patients unlikely to benefit are those not needing a biopsy or those with lesions outside the study criteria or contraindications to biopsy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial compares two MRI-targeted biopsy methods in men aged 50-75 with PI-RADS 3-5 lesions. Participants are assigned to transperineal cognitive fusion biopsy or transrectal cognitive fusion biopsy to see which method better detects clinically significant cancer and has fewer complications. Secondary outcomes include overall cancer detection, Gleason Grade Group ≥2 detection, infectious and other complications, pain, and procedure duration. The study will enroll 280 participants at Ankara Etlik City Hospital to determine non-inferiority of the transperineal approach regarding csPCa detection. Results may influence biopsy approach decisions and patient safety considerations in mpMRI-guided prostate cancer evaluation.
Why it matters
Potential benefit: If successful, patients may benefit from a safer biopsy method with similar cancer-detection performance and potentially fewer infectious complications.
How similar studies have gone: Previous data suggest transperineal approaches may reduce infectious complications, but this study tests non-inferiority in diagnostic performance for cognitive fusion biopsy.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Ankara Etlik City Hospital
Ankara, Yenimahalle, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: MUHAMMED Y AYDIN, Doctor
- Email: mysfa63@gmail.com
- Phone: +90 554 838 4510
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.