Trials / Withdrawn
WithdrawnNCT05815316
18F-PSMA PET/MRI for the Diagnosis of Clinically Significant Prostate Cancer
Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- IRCCS San Raffaele · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This project aims to evaluate the role of fully hybrid PET/MRI with 18F-PSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa). This prospective PET/MRI clinical evaluation will ideally 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 demonstration that, compared to mpMRI alone, the use of PET/MRI with 18F-PSMA has a superior diagnostic accuracy in detecting men with csPCa will strongly support the inclusion of 18F-PSMA as pre-biopsy triage test, in addition to mpMRI in daily clinical practice.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 18F-PSMA-1007 | (3S, 10S, 14S)-1-\[4-\[\[(2S)-4-carboxy-3-\[(2S)-4-carboxy-2-(6-\[18F\]fluoropyridin-3- amido)butanamido\]butanamido\]methyl\]phenyl\]-3- \[(naphtalen-2-yl)methyl\]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane- 10,14,16-tricarboxilyc acid |
Timeline
- Start date
- 2023-04-30
- Primary completion
- 2025-07-31
- Completion
- 2026-04-29
- First posted
- 2023-04-18
- Last updated
- 2025-04-13
Source: ClinicalTrials.gov record NCT05815316. Inclusion in this directory is not an endorsement.