Role of PET-CT with PSMA for equivocal MRI in prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter randomized study, men with MRI that is equivocal for prostate cancer are assigned to MRI-guided biopsy alone or to MRI plus PSMA PET-guided biopsy. Clinically significant cancer is defined as ISUP grade group 2 or higher. The goal is to see if the combined MRI+PSMA approach detects more csPCa and leads to different management than MRI alone. The trial uses a 1:1 randomization and compares detection rates and subsequent clinical decisions between arms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men ≥18 years of age
* Serum Prostate-specific antigen (PSA) 4-15 ng/mL, repeated at least once
* Prostate mpMRI done within 18 months
* MRI prostate with PI-RADS (11) scores of:

  * PI-RADS score 2 with red flag (PSA density \>0.2 OR Prostate health index, PHI\>35),
  * PI-RADS 3, OR
  * PI-RADS 4 with lower csPCa risks (PSAd \<0.1 OR PHI\<35)
* Normal Digital rectal examination
* Patient agrees for targeted and systematic prostate biopsy

Exclusion Criteria:

* Prostate biopsy within past 5 years
* Past or current history of prostate cancer
* Contraindicated to undergo PSMA PET-CT scan
* Contraindicated to prostate biopsy: active urinary tract infection, fail insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (keep aspirin before and after biopsy is permitted)

Where it's running

• Prince of Wales Hospital
  Hong Kong, Hong Kong Recruiting

Study contacts

• Principal investigator: Peter Ka-Fung CHIU — Chinese University of Hong Kong
• Study coordinator: Peter Ka-Fung CHIU
• Email: peterchiu@surgery.cuhk.edu.hk
• Phone: +852 35052625

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.