Back to results18F-PSMA PET/MRI for the Diagnosis of Clinically Significant Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
18F-PSMA-1007
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria: Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy Feasibility to undergo all procedures listed in protocol Ability to provide written informed consent Exclusion Criteria: Prior diagnosis of prostate cancer Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min) Contraindication to prostate biopsy
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-PSMA-1007
Arm Description
All patients undergo the same experimental procedure
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05815316
Brief Title
18F-PSMA PET/MRI for the Diagnosis of Clinically Significant Prostate Cancer
Official Title
Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 30, 2023 (Anticipated)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
April 29, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
167 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
18F-PSMA-1007
Arm Type
Experimental
Arm Description
All patients undergo the same experimental procedure
Intervention Type
Drug
Intervention Name(s)
18F-PSMA-1007
Intervention 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
Primary Outcome Measure Information:
Title
To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of csPCa
Description
Diagnostic accuracy measured with sensitivity, specificity, positive and negative predicted value
Time Frame
Biopsy at day 90 (+/-90)
Title
To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone
Description
The number of csPCa missed by PET and MR imaging when read independently
Time Frame
Biopsy at day 90 (+/-90)
Title
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.
Description
Only in patients with positive mpMRI and negative 18F-PSMA PET: The proportion of clinically insignificant PCa
Time Frame
Biopsy at day 90 (+/-90)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy
Feasibility to undergo all procedures listed in protocol
Ability to provide written informed consent
Exclusion Criteria:
Prior diagnosis of prostate cancer
Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)
Contraindication to prostate biopsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Picchio, MD
Phone
+390226436117
Email
picchio.maria@hsr.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
18F-PSMA PET/MRI for the Diagnosis of Clinically Significant Prostate Cancer
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