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

NCT04910425 | Withdrawn Phase 2 DMC FDA Drug

• 4 other identifiers: NU 19U05NCI-2021-05593STU00212326P30CA060553
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 18-F-DCFPyL positron emission tomography (PET) vs multiparametric magnetic resonance imaging (mpMRI) for the diagnosis of clinically significant prostate cancer in biopsy naïve men.

  Will be compared to multiparametric magnetic resonance imaging (mpMRI) for the diagnosis of clinically significant prostate cancer in biopsy naive men as defined by Gleason score \>= 3+4 (International Society of Urological Pathology \[ISUP\] group \>=2).

  Up to 30 days

Secondary Outcomes (1)

• Sensitivity of combined PET-mpMRI to mpMRI

  Up to 30 days

Study Arms (1)

Diagnostic (18F-DCFPyL PET/MRI, mpMRI)

EXPERIMENTAL

Patients receive fluorine F 18 DCFPyL IV and undergo PET/MRI. Patients also receive either gadobutrol IV or gadobenate dimeglumine IV (per radiologist preference), and undergo mpMRI. Within approximately 60 days after PET/MRI and mpMRI, patients undergo TRUS guided prostate biopsy per standard of care.

Drug: Fluorine F 18 DCFPyL; Drug: Gadobenate Dimeglumine; Drug: Gadobutrol; Procedure: Magnetic Resonance Imaging; Procedure: Multiparametric Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Transrectal Ultrasonography Guided Biopsy

Interventions

Fluorine F 18 DCFPyL DRUG

Given IV

Also known as: 18F-DCFPyL

Diagnostic (18F-DCFPyL PET/MRI, mpMRI)

Gadobenate Dimeglumine DRUG

Given IV

Also known as: Gd-BOPTA, MultiHance

Diagnostic (18F-DCFPyL PET/MRI, mpMRI)

Gadobutrol DRUG

Given IV

Also known as: BAY86-4875, Gadavist, Gadograf, Gadovist, Protovis, ZK 135079

Diagnostic (18F-DCFPyL PET/MRI, mpMRI)

Magnetic Resonance Imaging PROCEDURE

Undergo PET/MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Diagnostic (18F-DCFPyL PET/MRI, mpMRI)

Multiparametric Magnetic Resonance Imaging PROCEDURE

Undergo mpMRI

Also known as: MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

Diagnostic (18F-DCFPyL PET/MRI, mpMRI)

Positron Emission Tomography PROCEDURE

Undergo PET/MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Diagnostic (18F-DCFPyL PET/MRI, mpMRI)

Transrectal Ultrasonography Guided Biopsy PROCEDURE

Undergo TRUS-guided biopsy

Also known as: TRUS Biopsy, TRUS-Guided Biopsy

Diagnostic (18F-DCFPyL PET/MRI, mpMRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a positive screen for prostate cancer as confirmed by a prostate specific antigen (PSA) \>= 2 ng/ml
• Patients must elect to elect to undergo PHI blood test and TRUS-guided elect to undergo PHI blood test and TRUS-guided biopsy as part of routine clinical care
• Patients must be age \>= 18 years
• Patients must agree to use adequate contraception (e.g. Barrier method of birth control; abstinence) for 24 hours following completion of 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 had a prior biopsy for prostate cancer
• Patients who have contraindications to MRI (i.e. pacemakers, aneurysm clips or shaped fragments) are not eligible
• Patients receiving any other treatments or investigational agents are not eligible
• Patients administered a radioisotope \< 5 physical half-lives prior to the date of study PET/MRI
• Patients administered IV X-ray contrast medium \< 120 hours prior to the date of study PET/MRI
• Patients who report taking multivitamins on the day of study PET/MRI

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid; gadobenic acid; gadobutrol; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Edward M Schaeffer, MD/PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 2, 2021
• Study Start: June 17, 2023
• Primary Completion (Estimated): June 17, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 21, 2025

Record last verified: 2025-10

Locations

US (1)