18F-PSMA PET/MRI for the Diagnosis of Clinically Significant Prostate Cancer
NCT ID: NCT05815316
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2023-04-30
2026-04-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.
NCT06305390
A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer
NCT05712174
18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients
NCT05141760
PSMA PET/CT vs. mpMRI in Patients With a High Suspicion of Prostate Cancer: a Head to Head, Parallel, Prospective Trial
NCT05297162
18F-PSMA-1007 PET Imaging to Detect Primary Prostate Cancer
NCT04487847
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
18F-PSMA-1007
All patients undergo the same experimental procedure
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Feasibility to undergo all procedures listed in protocol
3. Ability to provide written informed consent
Exclusion Criteria
2. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)
3. Contraindication to prostate biopsy
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS San Raffaele
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Maria Picchio
Associate Professor
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RF-2021-12372278
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.