Status:
WITHDRAWN
PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well 18F-DCFPyL positron emission tomography (PET)/magnetic resonance imaging (MRI) works for the diagnosis of prostate cancer in men with a PSA greater than or equal t...
Detailed Description
PRIMARY OBJECTIVE: 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 na...
Eligibility Criteria
Inclusion
- Patients must have a positive screen for prostate cancer as confirmed by a prostate specific antigen (PSA) \>= 2 ng/ml
- 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
- Patients who have had a prior biopsy for prostate cancer
- 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 with a glomerular filtration rate (GFR) \< 30mL/min are ineligible to receive intravenous contrast per standard magnetic resonance (MR) exclusion criteria
- 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
Key Trial Info
Start Date :
June 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04910425
Start Date
June 17 2023
End Date
July 1 2028
Last Update
October 21 2025
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611