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Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial

RecruitingNAAges 18 Years - anyMaleChinese University of Hong Kong
NCT06303622 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Men ≥18 years of age * Clinical suspicion of prostate cancer and indicated for prostate biopsy * Serum Prostate-specific antigen (PSA) \< 20 ng/mL * Digital rectal examination ≤ cT2 (organ-confined cancer) * Able to provide written informed consent * MRI prostate (contrast or plain) showing 1-3 suspicious lesion(s) with PI-RADS score 3-5 Exclusion Criteria: * Prior prostate biopsy in the 2 years before screening visit * Prior diagnosis of prostate cancer * Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted) * Patient refusal for biopsy
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What it tests

  • MRI-USG fusion approach
  • Cognitive-guided approach
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Where

1 site
Prince of Wales Hospital
Hong Kong, Hong Kong
🤝 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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