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Genital Neoplasms, Male

Urogenital Neoplasms

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Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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Computed Tomography

Fluorine F 18 DCFPyL

Laboratory Biomarker Analysis

Positron Emission Tomography

Andrei Iagaru

This study provides fluorine F 18 DCFPyL positron emission tomography/computed tomography (PET/CT) to participants with prostate cancer that has come back. Diagnostic procedures, such as fluorine F 18 DCFPyL PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.

PRIMARY OBJECTIVES:

I. To evaluate fluorine F 18 DCFPyL (18F-DCFPyL) PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated prostate-specific antigen (PSA).

OUTLINE:

Participants receive fluorine F 18 DCFPyL intravenously (IV). After 60-120 minutes, participants undergo whole body PET/CT. Immediately after the first scan, participants may undergo a second PET/CT without receiving fluorine F 18 DCFPyL.

After completion of study, participants are followed up at 24-72 hours.

F18 DCFPyL PET/CT in Imaging Participants With Recurrent Prostate Cancer

18F-DCFPyL PET/CT in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer and Non-Contributory CT Scans

Associate Professor of Radiology

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.

Gadobenate Dimeglumine

Gadobutrol

Magnetic Resonance Imaging

Multiparametric Magnetic Resonance Imaging

Transrectal Ultrasonography Guided Biopsy

Study Coordinator

Edward M. Schaeffer

Edward M Schaeffer, MD/PhD

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.

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.

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

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).

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).

National Cancer Institute (NCI)

Northwestern University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
F18 DCFPyL PET/CT in Imaging Participants With Recurrent Prostate Cancer	NCT03501940	Prostate Adenoc... PSA Level Great... PSA Level Great... PSA Progression Recurrent Prost...	Computed Tomogr... Fluorine F 18 D... Laboratory Biom... Positron Emissi...	18 Years -	Stanford University
PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer	NCT04910425	Prostate Carcin...	Fluorine F 18 D... Gadobenate Dime... Gadobutrol Magnetic Resona... Multiparametric... Positron Emissi... Transrectal Ult...	18 Years -	Northwestern University
F18 DCFPyL PET/CT in Imaging Participants With Recurrent Prostate Cancer	NCT03501940	Prostate Adenoc... PSA Level Great... PSA Level Great... PSA Progression Recurrent Prost...	Computed Tomogr... Fluorine F 18 D... Laboratory Biom... Positron Emissi...	18 Years -	Stanford University
PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer	NCT04910425	Prostate Carcin...	Fluorine F 18 D... Gadobenate Dime... Gadobutrol Magnetic Resona... Multiparametric... Positron Emissi... Transrectal Ult...	18 Years -	Northwestern University
F18 DCFPyL PET/CT in Imaging Participants With Recurrent Prostate Cancer	NCT03501940	Prostate Adenoc... PSA Level Great... PSA Level Great... PSA Progression Recurrent Prost...	Computed Tomogr... Fluorine F 18 D... Laboratory Biom... Positron Emissi...	18 Years -	Stanford University

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