PET/MRI for the Staging of Newly Diagnosed Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

PET/MRI for the Staging of Newly Diagnosed Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03392181
• Other study ID #: NU 17U12
• Secondary ID: STU00205957NCI-2
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 8, 2018
• Est. completion date: June 1, 2023

Study information

• Verified date: February 2020
• Source: Northwestern University
• Contact: Mary Kate Keeter, MPH
• Phone: 3125035359
• Email: mary.fitzgerald[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Progenics Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET/MR versus mp-MRI for the Staging of Newly Diagnosed Prostate Cancer	To determine if PSMA-Targeted PET/MRI improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone.	5 years