Scan Combining PET and MRI to Diagnose Serious Prostate Cancer
Tests a combined PET and MRI scan in men suspected of having prostate cancer.
Key facts
- Who runs it
- IRCCS San Raffaele
- Where
- Milan, ItalySee the site
- Trial code
- Registry title
- Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 167 people, planned
- Started
- 4 Dec 2023
- Expected to end
- Apr 2027
- Type of study
- Interventional
- Treatments tested
- PET/MRI
- Record updated
- 1 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with a suspicion of prostate cancer who are referred for a prostate biopsy. It tests PET/MRI with 18F-PSMA as a one-stop way to diagnose significant prostate cancer.
- Age
- At least 18 years
- Sex
- Men only
- Disease stage
- Clinical suspicion of prostate cancer, referred for prostate biopsy. No prostate cancer diagnosed yet.
Main reasons for not taking part
- Prior diagnosis of prostate cancer
- Cannot have an MRI (for example claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)
- Cannot have a prostate biopsy
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in Italy
- U.O. of Nuclear Medicine, ,Ospedale San RaffaeleMilan, ItalyContact: Maria Picchio, MDTaking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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.
The group in the trial
- single armTreatment being tested
Treatment: PET/MRI
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.
- Plain-language title
- Scan Combining PET and MRI to Diagnose Serious Prostate CancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 1 April 2026