PET/MRI for the Staging of Newly Diagnosed Prostate Cancer

February 25, 2020 updated by: Edward Schaeffer, Northwestern University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Edward Schaeffer, MD/PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Progenics Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Edward Schaeffer, MD/PhD, Chair, Department of Urology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2018

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 5, 2018

Study Record Updates

Last Update Posted (Actual)

February 27, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU 17U12
  • STU00205957 (Other Identifier: Northwestern IRB)
  • NCI-2018-00059 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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