Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.
Recruiting · NCT06305390 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
PET/MRI
What this trial is about
This project aims to evaluate the role of fully hybrid PET/MRI with 18FPSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa). Our main hypothesis is that adding 18F-PSMA PET to mpMRI prior to biopsy, will reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy
- Feasibility to undergo all procedures listed in protocol
- Ability to provide written informed consent
Exclusion criteria
- Prior diagnosis of prostate cancer
- Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)
- Contraindication to prostate biopsy
Where it is running
1 location listed.
- U.O. of Nuclear Medicine, ,Ospedale San Raffaele - Milan, Milano, Italy