A Phase 2 interventional study of 18F-PSMA-1007 in Prostate Cancer, sponsored by IRCCS San Raffaele. Withdrawn. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-13.
Sponsored by IRCCS San Raffaele · Phase 2, Interventional, and Diagnostic
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,399 are open to participants now.
Browse Prostatic Neoplasms studies →IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.
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Exclusion Criteria:
All patients undergo the same experimental procedure
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
To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of csPCa
Diagnostic accuracy measured with sensitivity, specificity, positive and negative predicted value
Time frame: Biopsy at day 90 (+/-90)
To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone
The number of csPCa missed by PET and MR imaging when read independently
Time frame: Biopsy at day 90 (+/-90)
To report the change in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET, and consequently the proportion of unnecessary biopsies potentially spared.
Only in patients with positive mpMRI and negative 18F-PSMA PET: The proportion of clinically insignificant PCa
Time frame: Biopsy at day 90 (+/-90)
No study locations are listed for this record.
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Plan to share: No
This study is withdrawn, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele