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Prostate CarcinomaPhase 2NCT04910425

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

A Phase 2 study testing Fluorine F 18 DCFPyL, Gadobenate Dimeglumine and Gadobutrol in people with Prostate Carcinoma, run by Northwestern University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Carcinoma
What is being tested?
Fluorine F 18 DCFPyL, Gadobenate Dimeglumine and Gadobutrol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
17 Jun 2023to Jul 2028
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Fluorine F 18 DCFPyL, Gadobenate Dimeglumine, Gadobutrol, Magnetic Resonance Imaging, Multiparametric Magnetic Resonance Imaging
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluorine F 18 DCFPyLDrug

    Also called 18F-DCFPyL

    Given IV

  • Gadobenate DimeglumineDrug

    Also called Gd-BOPTA, MultiHance

    Given IV

  • GadobutrolDrug

    Also called BAY86-4875, Gadavist, Gadograf, Gadovist

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI

    Undergo PET/MRI

  • Multiparametric Magnetic Resonance ImagingProcedure or surgery

    Also called MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

    Undergo mpMRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PET/MRI

  • Transrectal Ultrasonography Guided BiopsyProcedure or surgery

    Also called TRUS Biopsy, TRUS-Guided Biopsy

    Undergo TRUS-guided biopsy

Study groups in NCT04910425
Study groupRoleWhat they receive
Diagnostic (18F-DCFPyL PET/MRI, mpMRI)ExperimentalPatients 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to 30 days

Secondary outcomes (1)

  1. Sensitivity of combined PET-mpMRI to mpMRI

    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).

    Measured: Up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2021
  2. Study start17 Jun 2023 (estimated)
  3. Primary completion17 Jun 2026 (estimated)
  4. Study completionJul 2028 (estimated)

Why it stopped: Study aborted

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04910425
Sponsor's protocol ID
NU 19U05
Other IDs
NCI-2021-05593, STU00212326, NU 19U05, P30CA060553
Status last verified
Oct 2025
First submitted
27 May 2021
Last updated
21 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluorine F 18 DCFPyL, Gadobenate Dimeglumine and Gadobutrol in people with Prostate Carcinoma, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04910425.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.

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