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

Launched by CHINESE UNIVERSITY OF HONG KONG · Mar 8, 2024

Keywords

ClinConnect Summary

The PROFUSION Trial is a clinical study aimed at finding out which method is better for detecting clinically significant prostate cancer in men who have suspicious MRI results. The researchers will compare two techniques: one that relies on a doctor's experience and judgment (cognitive-guided biopsy) and another that combines MRI images with ultrasound technology (MRI-ultrasound fusion biopsy). This trial is important because it aims to improve how doctors find prostate cancer early, which can lead to better treatment outcomes.

To participate in the trial, men aged 18 and older who have been advised to get a prostate biopsy may qualify, especially if they have certain MRI findings and a prostate-specific antigen (PSA) level below 20 ng/mL. However, individuals who have had a prostate biopsy in the last two years or already have a prostate cancer diagnosis cannot join. Participants will provide written consent before the study begins and will undergo the biopsy procedures to help researchers understand which method works best. It’s also worth noting that the trial is not yet recruiting participants, so it’s still in the planning stages.

Gender

MALE

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