Comparing two biopsy methods for detecting significant prostate cancer
A Randomised Controlled Trial Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of Clinically Significant Prostate Cancer: the PROFUSION Trial
This study is testing whether a new MRI-ultrasound fusion biopsy method can find significant prostate cancer better than the traditional cognitive-guided biopsy in men with suspicious MRI results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1250 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06303622 on ClinicalTrials.gov |
What this trial studies
This international multicentre randomized controlled trial aims to compare the effectiveness of MRI-ultrasound fusion-guided biopsies versus cognitive-guided biopsies in detecting clinically significant prostate cancer in men with suspicious MRI lesions. The study will evaluate whether the MRI-USG fusion approach is superior in detecting prostate cancer compared to the cognitive-guided method. The results could influence future practices in MRI-guided prostate biopsies and potentially establish a new standard of care if the MRI-USG fusion method proves to be more effective.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 18 and older with clinical suspicion of prostate cancer who are indicated for a prostate biopsy.
Not a fit: Patients who have previously been diagnosed with prostate cancer or those who are contraindicated for a biopsy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection rates of clinically significant prostate cancer, allowing for earlier and more effective treatment.
How similar studies have performed: Previous studies have shown promising results with MRI-guided biopsy techniques, suggesting that this approach may enhance cancer detection rates.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Peter Ka-Fungq CHIU — Chinese University of Hong Kong
- Study coordinator: Peter Ka-Fungq CHIU, PhD
- Email: peterchiu@surgery.cuhk.edu.hk
- Phone: 35052625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.