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

RECRUITINGN/ASponsored by Chinese University of Hong Kong
Actively Recruiting
PhaseN/A
SponsorChinese University of Hong Kong
Started2025-01-08
Est. completion2026-12-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06303622

Summary

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.

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

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