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PET/MRI for the Staging of Newly Diagnosed Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03392181
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : February 27, 2020
Sponsor:
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Edward Schaeffer, Northwestern University

Tracking Information
First Submitted Date  ICMJE January 2, 2018
First Posted Date  ICMJE January 5, 2018
Last Update Posted Date February 27, 2020
Actual Study Start Date  ICMJE June 8, 2018
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PET/MRI for the Staging of Newly Diagnosed Prostate Cancer
Official Title  ICMJE PET/MRI for the Staging of Newly Diagnosed Prostate Cancer
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 and in determining the stage of prostate cancer before surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: 18F-DCFPyL
Intervention: Drug: 18F-DCFPyL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 2, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2023
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mary Kate Keeter, MPH 3125035359 mary.fitzgerald@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03392181
Other Study ID Numbers  ICMJE NU 17U12
STU00205957 ( Other Identifier: Northwestern IRB )
NCI-2018-00059 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Edward Schaeffer, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Progenics Pharmaceuticals, Inc.
Investigators  ICMJE
Principal Investigator: Edward Schaeffer, MD/PhD Chair, Department of Urology
PRS Account Northwestern University
Verification Date February 2020

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