PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer

Summary

This phase II trial studies how well 18F-DCFPyL positron emission tomography (PET)/magnetic resonance imaging (MRI) works for the diagnosis of prostate cancer in men with a PSA greater than or equal to 2 ng/mL. 18F-DCFPyl is a radioactive injectable imaging agent made of a prostate specific membrane antigen (PSMA) that attaches to tumor cells, which makes it useful for the diagnosis of prostate cancer. A PET scan is an imaging tool that may help find the location of cancer, by using a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. A mp-MRI is used to help determine the extent of a patient's cancer. A MRI scan uses strong magnets and computers to create detailed images of the soft tissue in the body. This trial aims to compare PET scans to prostate specific mp-MRI to evaluate prostate cancer severity in men with a positive screen for prostate cancer.

Conditions

• Prostate Carcinoma

Interventions

DRUG

Fluorine F 18 DCFPyL

Given IV

DRUG

Gadobenate Dimeglumine

Given IV

DRUG

Gadobutrol

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo PET/MRI

PROCEDURE

Multiparametric Magnetic Resonance Imaging

Undergo mpMRI

PROCEDURE

Positron Emission Tomography

Undergo PET/MRI

PROCEDURE

Transrectal Ultrasonography Guided Biopsy

Undergo TRUS-guided biopsy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Northwestern University

  lead OTHER

Principal Investigators

• Edward M Schaeffer, MD/PhD · Northwestern University

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-17

Primary Completion

2026-06-17

Completion

2028-07-31

FDA Drug

Yes

Countries

• United States

Study Locations