Status:
ACTIVE_NOT_RECRUITING
PET/MRI for the Staging of Newly Diagnosed Prostate Cancer
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Progenics Pharmaceuticals, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18-89 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to gain understanding of how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer a...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients must have a biopsy-proven diagnosis of high risk, very high risk, or locally advanced prostate cancer
- 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 have contraindications to MRI (i.e. pacemakers, aneurysm clips or shaped fragments)
- 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 with a GFR \<30mL/min are ineligible to receive intravenous contrast per standard MR exclusion criteria
- 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
Exclusion
Key Trial Info
Start Date :
June 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03392181
Start Date
June 8 2018
End Date
June 1 2026
Last Update
May 23 2025
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611