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PET/MRI for the Staging of Newly Diagnosed Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-DCFPyL
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-DCFPyL

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 2, 2018
Last Updated
February 25, 2020
Sponsor
Northwestern University
Collaborators
Progenics Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03392181
Brief Title
PET/MRI for the Staging of Newly Diagnosed Prostate Cancer
Official Title
PET/MRI for the Staging of Newly Diagnosed Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 8, 2018 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Progenics Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-DCFPyL
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
18F-DCFPyL
Intervention Description
To determine whether PET/MR utilizing PYL improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone.
Primary Outcome Measure Information:
Title
PET/MR versus mp-MRI for the Staging of Newly Diagnosed Prostate Cancer
Description
To determine if PSMA-Targeted PET/MRI improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone.
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Kate Keeter, MPH
Phone
3125035359
Email
mary.fitzgerald@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Schaeffer, MD/PhD
Organizational Affiliation
Chair, Department of Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Kate Keeter, MPH
Phone
312-503-5359
Email
mary.fitzgerald@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Edward Schaeffer, MD/PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PET/MRI for the Staging of Newly Diagnosed Prostate Cancer

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