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PET/MRI for the Staging of Newly Diagnosed Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03392181
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Edward Schaeffer, Northwestern University

January 2, 2018
January 5, 2018
June 13, 2018
June 8, 2018
May 1, 2023   (Final data collection date for primary outcome measure)
PET/MR versus mp-MRI for the Staging of Newly Diagnosed Prostate Cancer [ Time Frame: 5 years ]
To determine if PSMA-Targeted PET/MRI improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone.
Same as current
Complete list of historical versions of study NCT03392181 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
PET/MRI for the Staging of Newly Diagnosed Prostate Cancer
PET/MRI for the Staging of Newly Diagnosed Prostate Cancer
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 and in determining the stage of prostate cancer before surgery.
Not Provided
Interventional
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Prostate Cancer
Drug: 18F-DCFPyL
To determine whether PET/MR utilizing PYL improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone.
Experimental: 18F-DCFPyL
Intervention: Drug: 18F-DCFPyL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
Same as current
June 1, 2023
May 1, 2023   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 89 Years   (Adult, Older Adult)
No
Contact: Mary Kate Keeter, MPH 3125035359 mary.fitzgerald@northwestern.edu
United States
 
 
NCT03392181
NU 17U12
STU00205957 ( Other Identifier: Northwestern IRB )
NCI-2018-00059 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Edward Schaeffer, Northwestern University
Northwestern University
Progenics Pharmaceuticals, Inc.
Principal Investigator: Edward Schaeffer, MD/PhD Chair, Department of Urology
Northwestern University
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP