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Transperineal Versus Transrectal Cognitive Fusion Prostate Biopsy

RecruitingNAAges 50 Years - 75 YearsMaleAnkara Etlik City Hospital
NCT07710807 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 proc

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📋 Eligibility rules (as published)
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.
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What it tests

  • Transrectal Cognitive Fusion Prostate Biopsy
  • Transperineal Cognitive Fusion Prostate Biopsy
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Where

1 site
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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