PET/MRI for the Staging of Newly Diagnosed Prostate Cancer
NCT ID: NCT03392181
Last Updated: 2025-05-23
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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ACTIVE_NOT_RECRUITING
EARLY_PHASE1
48 participants
INTERVENTIONAL
2018-06-08
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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18F-DCFPyL
18F-DCFPyL
To determine whether PET/MR utilizing PYL improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone.
Interventions
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18F-DCFPyL
To determine whether PET/MR utilizing PYL improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone.
Eligibility Criteria
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Inclusion Criteria
* Patients must have a diagnosis of high risk, very high risk, or locally advanced prostate cancer per NCCN Guidelines (T3-T4 disease)
* Patients are healthy enough to be deemed surgical candidates with an ECOG performance status of 0-2
* Patients must be age ≥ 18 years
* Patients must agree to use adequate contraception (e.g. barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of the 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 are claustrophobic will be required to take an anti-anxiety medication prescribed by their physician one hour prior to the scan
* Patients may not be receiving any other treatments or investigational agents
* Patients not interested in pursuing surgical intervention for their disease (i.e. refusing treatment or requesting radiation oncology referral)
* Patients who have received androgen deprivation therapy or prior surgery for prostate cancer
* Patients who report taking multivitamins and/or folate supplements on the day of the scan
18 Years
89 Years
MALE
No
Sponsors
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Progenics Pharmaceuticals, Inc.
INDUSTRY
Northwestern University
OTHER
Responsible Party
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Edward Schaeffer
Chair, Department of Urology, Program of Director for GU Oncology
Principal Investigators
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Edward Schaeffer, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Chair, Department of Urology
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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References
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Li EV, Schaeffer EM, Ramesh Kumar SKS, Zhou R, Yang XJ, Mana-Ay M, Vescovo M, Ho A, Keeter MK, Carr J, Casalino D, Kocherginsky M, Patel HD, Ross AE, Savas H. Utility of 18F-DCFPyL PET for local staging for high or very high risk prostate cancer for patients undergoing radical prostatectomy. Eur J Nucl Med Mol Imaging. 2025 Jun;52(7):2335-2342. doi: 10.1007/s00259-025-07133-1. Epub 2025 Feb 10.
Other Identifiers
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STU00205957
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2018-00059
Identifier Type: REGISTRY
Identifier Source: secondary_id
NU 17U12
Identifier Type: -
Identifier Source: org_study_id
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