18F-FMAU PET/CT in Diagnosing and Characterizing Prostate Cancer

University of Southern California

Status and phase: Terminated; Phase 1

Conditions: Prostate Neoplasm

Treatments: Device: Ultrasound; Procedure: Multiparametric Magnetic Resonance Imaging; Drug: 18F-FMAU; Device: Positron Emission Tomography; Device: CAT; Other: Laboratory Biomarker Analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02809690

NCI-2016-00814 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

R21EB017568 (U.S. NIH Grant/Contract)

4P-16-3 (Other Identifier)

Details and patient eligibility

About

This pilot clinical trial studies how well fluorine F 18 d-FMAU (18F-FMAU) positron emission tomography (PET)/computed tomography (CT) works in diagnosing and characterizing prostate cancer. A PET/CT scan is an imaging test that uses a small amount of radioactive tracer that is given through the vein to take detailed pictures of areas inside the body where the tracer is taken up. Radiotracers such as 18F-FMAU may help to find the cancer and see how far the disease has spread.

Full description

PRIMARY OBJECTIVES:

I. To perform a prospective clinical imaging evaluation of 18F-FMAU PET/CT in addition to multiparametric magnetic resonance imaging (mpMRI) and standard transrectal ultrasound (TRUS)-guided 12-core biopsy for detection and localization of primary tumor in 40 men with suspected prostate cancer based on elevated/rising prostate specific antigen level, abnormal digital rectal exam, or those with prior negative standard biopsy who are now returning for a standard of care follow-up.

II. To examine the associations between the PET derived imaging parameters, serum PSA, mpMRI parameters (apparent diffusion coefficient [ADC], Ktrans) and the biopsy histopathology parameters.

OUTLINE:

Patients receive radiotracer F 18 d-FMAU intravenously (IV) over 1 minute and then undergo 18F-FMAU PET/CT on day 1. Patients then undergo standard of care multiparametic MRI and standard of care transrectal ultrasound-guided biopsy.

After completion of study treatment, patients are followed up at 24-96 hours.

Enrollment: 18 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled to undergo standard of care biopsy for suspected prostate cancer, or re-biopsy with prior negative systemic biopsy or restaging biopsy in patients with known prostate cancer on active surveillance

Exclusion criteria

• History of myocardial infarction within 6 months of the enrollment
• Active infection (except mild upper respiratory infections)
• Active prostatitis
• Non-prostate cancers currently on treatment

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Diagnostic (18F-FMAU PET/CT)

Experimental group

Description:

Patients receive radiotracer F 18 d-FMAU IV over 1 minute and then undergo 18F-FMAU PET/CT on day 1. Patients then undergo standard of care multiparametic MRI and standard of care transrectal ultrasound-guided biopsy.

Treatment:

Device: CAT

Device: Positron Emission Tomography

Drug: 18F-FMAU

Device: Ultrasound

Procedure: Multiparametric Magnetic Resonance Imaging

Other: Laboratory Biomarker Analysis