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2024-512859-21-00RecruitingPhase 2

Fully hybrid 18F-PSMA PET/MRI as one-stop approach for the diagnosis of clinically significant prostate cancer

Source: EU CTIS (euclinicaltrials.eu) · Last updated 8 Sept 2026

Next steps

Brief summary (registry, in English)

To determine the diagnostic accuracy of 18F-PSMA PET/MRI for the diagnosis of clinically relevant prostate cancer

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
167 (estimated)
First submitted
20 Sept 2024
Start date
4 Dec 2023
Lead sponsor
Ospedale San Raffaele S.r.l.
EU CT number
2024-512859-21-00
EudraCT number
2022-003905-31

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 167
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

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 aged 18 or older who are suspected of having prostate cancer that matters clinically. It tests how well a 18F-PSMA PET/MRI scan finds this cancer.

Age
18 years or older
Sex
Men only
Disease stage
Suspected clinically significant prostate cancer, not yet diagnosed

Main reasons for not taking part

  • Already diagnosed with prostate cancer
  • Cannot have an MRI scan (for example claustrophobia, pacemaker, estimated GFR of 50 mls/min or less)
  • Cannot have a prostate biopsy

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous diagnosis of prostate cancer

Lab values

  • Contraindications to perform the MRI examination (e.g. claustrophobia, pacemaker, estimated GFR less than or equal to 50mls/min)

Other

  • Contraindications to perform the prostate biopsy

Who the study is looking for

  • Patients 18 years of age or older, identified as suspects for clinically significant prostate cancer
  • Ability to undergo all protocol scrutiny
  • Ability to provide informed consent

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Ospedale San Raffaele S.r.l.MilanItalyRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.