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Trial Title:
18F-PSMA PET/MRI for the Diagnosis of Clinically Significant Prostate Cancer
NCT ID:
NCT05815316
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18F-PSMA-1007
Description:
(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
Arm group label:
18F-PSMA-1007
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.
Criteria for 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 30, 2023
Completion date:
April 29, 2026
Lead sponsor:
Agency:
IRCCS San Raffaele
Agency class:
Other
Source:
IRCCS San Raffaele
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05815316
