Transperineal Versus Transrectal Cognitive Fusion Prostate Biopsy

Recruiting now · Not applicable

Conditions studied: Prostate Cancer, Clinically Significant Prostate Cancer, Cognitive Fusion

In brief

This prospective randomized controlled trial aims to compare transperineal and transrectal cognitive fusion prostate biopsy techniques in patients with suspicious prostate lesions detected by multiparametric magnetic resonance imaging (mpMRI). Patients aged 50-75 years with PI-RADS 3-5 lesions on mpMRI and an indication for prostate biopsy will be randomly assigned in a 1:1 ratio to undergo either transperineal cognitive fusion prostate biopsy or transrectal cognitive fusion prostate biopsy. The primary objective of this study is to evaluate whether transperineal cognitive fusion biopsy is non-inferior to transrectal cognitive fusion biopsy in detecting clinically significant prostate cancer (csPCa). Secondary objectives include comparison of overall prostate cancer detection rates, detection of Gleason Grade Group ≥2 prostate cancer, biopsy-related infectious complications, other procedure-related complications, pain scores, and procedure duration. A total of 280 participants will be enrolled. Pathological evaluation will be performed after biopsy, and clinical outcomes and complications will be assessed during follow-up.

Key facts

Study ID

NCT07710807

Run by

Ankara Etlik City Hospital

People needed

280

Starts

2026-06-01

Expected to finish

2027-03-31

Last updated by the study team

2026-07-17

Who can join

Age: 50 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Ankara Etlik City Hospital — Ankara, Yenimahalle, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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