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

October 20, 2025 updated by: Northwestern University

Phase II Study to Evaluate the Performance of PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Clinically Significant Prostate Cancer in Men Presenting Following a Positive Screen for Prostate Cancer

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Compare the fluorine F 18 DCFPyL (18-F-DCFPyL) PET 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).

SECONDARY OBJECTIVES:

I. Compare the combined 18-F-DCFPyL PET and mpMRI to mpMRI alone for the diagnosis of clinically significant prostate cancer in biopsy naive men as defined by Gleason score >= 3+4 (ISUP group >= 2).

II. Estimate the sensitivities and specificities of combined 18-F-DCFPyL PET/mpMRI, mpMRI alone, 18-F-DCFPyL PET alone, and prostate health index (PHI) alone for the diagnosis of clinically significant prostate cancer.

III. Estimate the accuracy of PET alone for the diagnosis of clinically significant prostate cancer in biopsy naïve men as defined by Gleason score >= 3+4 (ISUP group >=2).

IV. Compare the accuracy of PET to prostate health index (PHI) for the diagnosis of clinically significant prostate cancer in biopsy naive men as defined by Gleason score >= 3+4 (ISUP group >= 2).

OUTLINE:

Patients receive fluorine F 18 DCFPyL intravenously (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 transrectal ultrasound (TRUS) guided prostate biopsy per standard of care.

After completion of study intervention, patients are followed up within 24 hours, and then at 30 days.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 with a glomerular filtration rate (GFR) < 30mL/min are ineligible to receive intravenous contrast per standard magnetic resonance (MR) exclusion criteria
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (18F-DCFPyL PET/MRI, mpMRI)
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: Gadobutrol
Given IV
Other Names:
  • BAY86-4875
  • Gadavist
  • Gadograf
  • Gadovist
  • Protovis
  • ZK 135079
Procedure: Magnetic Resonance Imaging
Undergo PET/MRI
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Undergo PET/MRI
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
Procedure: Multiparametric Magnetic Resonance Imaging
Undergo mpMRI
Other Names:
  • Multiparametric MRI
  • MP-MRI
  • mpMRI
  • Multi-parametric MRI
Drug: Gadobenate Dimeglumine
Given IV
Other Names:
  • Gd-BOPTA
  • MultiHance
Drug: Fluorine F 18 DCFPyL
Given IV
Other Names:
  • 18F-DCFPyL
Procedure: Transrectal Ultrasonography Guided Biopsy
Undergo TRUS-guided biopsy
Other Names:
  • TRUS Biopsy
  • TRUS-Guided Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Up to 30 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of combined PET-mpMRI to mpMRI
Time Frame: Up to 30 days
Will be estimated and compared to mpMRI alone for the diagnosis of clinically significant prostate cancer in biopsy naive men as defined by Gleason score >= 3+4 (ISUP group >= 2).
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Edward M Schaeffer, MD/PhD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 17, 2023

Primary Completion (Estimated)

June 17, 2026

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

May 27, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Estimated)

October 21, 2025

Last Update Submitted That Met QC Criteria

October 20, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU 19U05 (Other Identifier: Northwestern University)
  • P30CA060553 (U.S. NIH Grant/Contract)
  • NCI-2021-05593 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • STU00212326

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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