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

Northwestern University

Status and phase

Withdrawn

Phase 2

Conditions

Prostate Carcinoma

Treatments

Drug: Fluorine F 18 DCFPyL

Procedure: Positron Emission Tomography

Procedure: Multiparametric Magnetic Resonance Imaging

Drug: Gadobutrol

Procedure: Magnetic Resonance Imaging

Drug: Gadobenate Dimeglumine

Procedure: Transrectal Ultrasonography Guided Biopsy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04910425

STU00212326

NU 19U05 (Other Identifier)

NCI-2021-05593 (Registry Identifier)

P30CA060553 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

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

Experimental group

Description:

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.