PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer
NCT ID: NCT04910425
Last Updated: 2025-10-21
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2023-06-17
2028-07-31
Brief Summary
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Detailed Description
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I. Compare the fluorine F 18 DCFPyL (18-F-DCFPyL) PET to multiparametric magnetic resonance imaging (mpMRI) for the diagnosis of clinically significant prostate cancer in biopsy naive men as defined by Gleason score \>= 3+4 (International Society of Urological Pathology \[ISUP\] group \>= 2).
SECONDARY OBJECTIVES:
I. Compare the combined 18-F-DCFPyL PET and mpMRI to mpMRI alone for the diagnosis of clinically significant prostate cancer in biopsy naive men as defined by Gleason score \>= 3+4 (ISUP group \>= 2).
II. Estimate the sensitivities and specificities of combined 18-F-DCFPyL PET/mpMRI, mpMRI alone, 18-F-DCFPyL PET alone, and prostate health index (PHI) alone for the diagnosis of clinically significant prostate cancer.
III. Estimate the accuracy of PET alone for the diagnosis of clinically significant prostate cancer in biopsy naïve men as defined by Gleason score \>= 3+4 (ISUP group \>=2).
IV. Compare the accuracy of PET to prostate health index (PHI) for the diagnosis of clinically significant prostate cancer in biopsy naive men as defined by Gleason score \>= 3+4 (ISUP group \>= 2).
OUTLINE:
Patients receive fluorine F 18 DCFPyL intravenously (IV) and undergo PET/MRI. Patients also receive either gadobutrol IV or gadobenate dimeglumine IV (per radiologist preference), and undergo mpMRI. Within approximately 60 days after PET/MRI and mpMRI, patients undergo transrectal ultrasound (TRUS) guided prostate biopsy per standard of care.
After completion of study intervention, patients are followed up within 24 hours, and then at 30 days.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (18F-DCFPyL PET/MRI, mpMRI)
Patients receive fluorine F 18 DCFPyL IV and undergo PET/MRI. Patients also receive either gadobutrol IV or gadobenate dimeglumine IV (per radiologist preference), and undergo mpMRI. Within approximately 60 days after PET/MRI and mpMRI, patients undergo TRUS guided prostate biopsy per standard of care.
Fluorine F 18 DCFPyL
Given IV
Gadobenate Dimeglumine
Given IV
Gadobutrol
Given IV
Magnetic Resonance Imaging
Undergo PET/MRI
Multiparametric Magnetic Resonance Imaging
Undergo mpMRI
Positron Emission Tomography
Undergo PET/MRI
Transrectal Ultrasonography Guided Biopsy
Undergo TRUS-guided biopsy
Interventions
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Fluorine F 18 DCFPyL
Given IV
Gadobenate Dimeglumine
Given IV
Gadobutrol
Given IV
Magnetic Resonance Imaging
Undergo PET/MRI
Multiparametric Magnetic Resonance Imaging
Undergo mpMRI
Positron Emission Tomography
Undergo PET/MRI
Transrectal Ultrasonography Guided Biopsy
Undergo TRUS-guided biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must elect to elect to undergo PHI blood test and TRUS-guided elect to undergo PHI blood test and TRUS-guided biopsy as part of routine clinical care
* Patients must be age \>= 18 years
* Patients must agree to use adequate contraception (e.g. Barrier method of birth control; abstinence) for 24 hours following completion of imaging
* Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
Exclusion Criteria
* Patients who have contraindications to MRI (i.e. pacemakers, aneurysm clips or shaped fragments) are not eligible
* Patients receiving any other treatments or investigational agents are not eligible
* Patients administered a radioisotope \< 5 physical half-lives prior to the date of study PET/MRI
* Patients administered IV X-ray contrast medium \< 120 hours prior to the date of study PET/MRI
* Patients who report taking multivitamins on the day of study PET/MRI
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
Responsible Party
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Principal Investigators
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Edward M Schaeffer, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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Other Identifiers
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NCI-2021-05593
Identifier Type: REGISTRY
Identifier Source: secondary_id
STU00212326
Identifier Type: -
Identifier Source: secondary_id
NU 19U05
Identifier Type: OTHER
Identifier Source: secondary_id
NU 19U05
Identifier Type: -
Identifier Source: org_study_id
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