Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03392181

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–89 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-DCFPyl

Drug

To determine whether PET/MR utilizing PYL improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Progenics Pharmaceuticals, Inc.

Registry information

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2018
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.