NCT06305390 Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.
| NCT ID | NCT06305390 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | IRCCS San Raffaele |
| Condition | Clinical Suspicion of Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 167 participants |
| Start Date | 2023-12-04 |
| Primary Completion | 2026-03-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 167 participants in total. It began in 2023-12-04 with a primary completion date of 2026-03-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy 2. Feasibility to undergo all procedures listed in protocol 3. Ability to provide written informed consent Exclusion Criteria: 1. Prior diagnosis of prostate cancer 2. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min) 3. Contraindication to prostate biopsy
Contact & Investigator
Arturo Chiti, MD
STUDY DIRECTOR
IRCCS Ospedale San Raffaele
Frequently Asked Questions
Who can join the NCT06305390 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Clinical Suspicion of Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06305390 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06305390 currently recruiting?
Yes, NCT06305390 is actively recruiting participants. Contact the research team at Picchio.maria@hsr.it for enrollment information.
Where is the NCT06305390 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06305390 clinical trial?
NCT06305390 is sponsored by IRCCS San Raffaele. The principal investigator is Arturo Chiti, MD at IRCCS Ospedale San Raffaele. The trial plans to enroll 167 participants.
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