NCT04910425

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-17
• Primary completion: 2026-06-17
• Completion: 2028-07-01
• First posted: 2021-06-02
• Last updated: 2025-10-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study