Transperineal Versus Transrectal Cognitive Fusion Prostate Biopsy

Recruiting · NCT07710807 · Interventional (participants receive a specific treatment) · Lead sponsor: Ankara Etlik City Hospital

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Prostate Cancer

Interventions studied

Transperineal Cognitive Fusion Prostate BiopsyTransrectal Cognitive Fusion Prostate Biopsy

What this trial is about

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.

Who can take part

Age range

50 Years to 75 Years

Sex

Male

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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 is running

1 location listed.

Ankara Etlik City Hospital - Ankara, Yenimahalle, Turkey (Türkiye)

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →