Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.
NCT ID: NCT06305390
Last Updated: 2024-10-16
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
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RECRUITING
167 participants
OBSERVATIONAL
2023-12-04
2026-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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single arm
PET/MRI
18F-PSMA PET/MRI
Interventions
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PET/MRI
18F-PSMA PET/MRI
Eligibility Criteria
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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
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IRCCS San Raffaele
OTHER
Responsible Party
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Chiti Arturo
PI
Principal Investigators
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Arturo Chiti, MD
Role: STUDY_DIRECTOR
IRCCS Ospedale San Raffaele
Locations
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U.O. of Nuclear Medicine, ,Ospedale San Raffaele
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-003905-31
Identifier Type: -
Identifier Source: org_study_id
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