PET/MRI for the Staging of Newly Diagnosed Prostate Cancer

Sponsor

Northwestern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03392181

Collaborator

Progenics Pharmaceuticals, Inc. (Industry)

Enrollment

Location

Arm

59.8

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Jun 8, 2018

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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.

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

Primary Outcome Measures

PET/MR versus mp-MRI for the Staging of Newly Diagnosed Prostate Cancer [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

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Northwestern University
Progenics Pharmaceuticals, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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
NCI-2018-00059

First Posted:

Jan 5, 2018

Last Update Posted:

Feb 27, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Feb 27, 2020