NCT03392181

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P75+ for early_phase_1 prostate-cancer

Timeline
1mo left

Started Jun 2018

Longer than P75 for early_phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2018Jun 2026

First Submitted

Initial submission to the registry

January 2, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

June 8, 2018

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

7.9 years

First QC Date

January 2, 2018

Last Update Submit

May 20, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

18F-DCFPyL

EXPERIMENTAL
Drug: 18F-DCFPyL

Interventions

18F-DCFPyLDRUG

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

18F-DCFPyL

Eligibility Criteria

Age18 Years - 89 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Li EV, Schaeffer EM, Ramesh Kumar SKS, Zhou R, Yang XJ, Mana-Ay M, Vescovo M, Ho A, Keeter MK, Carr J, Casalino D, Kocherginsky M, Patel HD, Ross AE, Savas H. Utility of 18F-DCFPyL PET for local staging for high or very high risk prostate cancer for patients undergoing radical prostatectomy. Eur J Nucl Med Mol Imaging. 2025 Jun;52(7):2335-2342. doi: 10.1007/s00259-025-07133-1. Epub 2025 Feb 10.

    PMID: 39928105DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Edward Schaeffer, MD/PhD

    Chair, Department of Urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Urology, Program of Director for GU Oncology

Study Record Dates

First Submitted

January 2, 2018

First Posted

January 5, 2018

Study Start

June 8, 2018

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)