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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 18F-DCFPyL Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET/MRI for the Staging of Newly Diagnosed Prostate Cancer
Actual Study Start Date : June 8, 2018
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 18F-DCFPyL 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392181


Contacts
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Contact: Mary Kate Keeter, MPH 3125035359 mary.fitzgerald@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Mary Kate Keeter, MPH    312-503-5359    mary.fitzgerald@northwestern.edu   
Principal Investigator: Edward Schaeffer, MD/PhD         
Sponsors and Collaborators
Northwestern University
Progenics Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Edward Schaeffer, MD/PhD Chair, Department of Urology
More Information
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Responsible Party: Edward Schaeffer, Chair, Department of Urology, Program of Director for GU Oncology, Northwestern University
ClinicalTrials.gov Identifier: NCT03392181    
Other Study ID Numbers: NU 17U12
STU00205957 ( Other Identifier: Northwestern IRB )
NCI-2018-00059 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases