- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06305390
Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer. (RF2021-1237227)
This project aims to evaluate the role of fully hybrid PET/MRI with 18FPSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa).
Our main hypothesis is that adding 18F-PSMA PET to mpMRI prior to biopsy, will 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Maria Picchio, MD
- Phone Number: 02-26436117
- Email: Picchio.maria@hsr.it
Study Contact Backup
- Name: Rachele Di Donato, PhD
- Phone Number: 02-26433639
- Email: didonato.rachele@hsr.it
Study Locations
-
-
-
Milano, Italy, 20132
- Recruiting
- U.O. of Nuclear Medicine, ,Ospedale San Raffaele
-
Contact:
- Maria Picchio, MD
- Phone Number: 02-26436117
- Email: Picchio.maria@hsr.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
single arm
|
18F-PSMA PET/MRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of clinically significant prostate cancer (csPCa)
Time Frame: PET/MRI: day 0 prostate biopsy: day 0-90 days
|
Diagnostic accuracies of 18F-PSMA PET and mpMRI will be calculated by means of sensitivity: true positive/(true positive + false negative) and specificity: true negative/(false positive + true negative) using the prostate biopsy result as reference standard.
|
PET/MRI: day 0 prostate biopsy: day 0-90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone To report the reduction in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET
Time Frame: PET/MRI: day 0 prostate biopsy: day 0-90 days
|
The proportion of csPCa (defined by analysis of prostate biopsy cores, ISUP grade equal or higher than 2) missed by PSMA PET scan or mpMRI alone will be calculated.
|
PET/MRI: day 0 prostate biopsy: day 0-90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Arturo Chiti, MD, IRCCS Ospedale San Raffaele
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-003905-31
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Clinical Suspicion of Prostate Cancer
-
IRCCS San RaffaeleRecruitingSuspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the ProstateItaly
-
CHU de ReimsUnknownSuspicion of Tumor of the Small IntestineFrance
-
Poitiers University HospitalTerminatedMen Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.France
-
Beth Israel Medical CenterRiverside Research InstituteCompletedClinical Stage T2b or Less of Prostate Cancer | Prostate Brachytherapy | Transrectal Prostate Ultrasound Treatment PlanningUnited States
-
Meridian Bioscience, Inc.CompletedSuspicion of Being Infected With H.PyloriUnited States
-
Memorial Sloan Kettering Cancer CenterCompleted
-
Women's College HospitalOttawa Hospital Research Institute; Cancer Care Ontario; Laval University; Ontario...CompletedClinical Trial | Early Detection of CancerCanada
-
Brahms AGRecruitingPatients Presenting With Suspicion of Infection to the EDUnited Kingdom, Spain, Italy, France
-
The University of Texas Health Science Center,...CompletedUnderstanding of Consent in Clinical Research | Implementation of Consent in Clinical ResearchUnited States
-
Assistance Publique - Hôpitaux de ParisNational Cancer Institute, FranceCompletedCancer | Elderly | Ethnographic Interview | Social Representation of Being Aged | Reasons of Non-participation in Clinical Trials | Qualitative MethodFrance
Clinical Trials on PET/MRI
-
Cambridge University Hospitals NHS Foundation TrustRecruitingBreast CancerUnited Kingdom
-
Jeffrey A. Lieberman, MDTerminated
-
New York State Psychiatric InstituteNational Institute of Mental Health (NIMH)TerminatedSchizophreniaUnited States
-
Maastricht University Medical CenterCompletedOvarian NeoplasmsNetherlands
-
Università Vita-Salute San RaffaeleIRCCS San Raffaele; Associazione Italiana per la Ricerca sul CancroNot yet recruitingBreast Cancer Female | Lobular Breast Carcinoma | Luminal A Breast Cancer | PET/MRI | Axillary Lymphadenopathy
-
University of EdinburghActive, not recruiting
-
NYU Langone HealthDendreonTerminatedProstate CancerUnited States
-
Washington University School of MedicineNational Cancer Institute (NCI)Terminated
-
Massachusetts General HospitalRecruiting
-
Xuzhou Medical UniversityUnknownProstate Cancer