NCT06303622 Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial
| NCT ID | NCT06303622 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,250 participants |
| Start Date | 2025-01-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,250 participants in total. It began in 2025-01-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Peter Ka-Fungq CHIU
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06303622 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06303622 currently recruiting?
Yes, NCT06303622 is actively recruiting participants. Contact the research team at peterchiu@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT06303622 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06303622 clinical trial?
NCT06303622 is sponsored by Chinese University of Hong Kong. The principal investigator is Peter Ka-Fungq CHIU at Chinese University of Hong Kong. The trial plans to enroll 1,250 participants.
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