NCT06305390RecruitingPhase 2
Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 167 (estimated)
- First submitted
- 5 Mar 2024
- Start date
- 4 Dec 2023
- Primary completion date
- 24 Mar 2026
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Prostate cancer
- NCT number
- NCT06305390
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 167
- From 4 Dec 2023 to the primary completion date, 24 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior diagnosis of prostate cancer
Lab values
- Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)
Other
- Contraindication to prostate biopsy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| U.O. of Nuclear Medicine, ,Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.