NCT02809690

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

Pilot Feasibility Study of 18F-FMAU PET for Diagnosing and Characterizing Prostate Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Prostate Neoplasm

Interventions

Type	Name	Description
DEVICE	CAT	Undergo 18F-FMAU PET/CT
DRUG	18F-FMAU	Patients receive radiotracer F 18 d-FMAU IV over 1 minute and then undergo 18F-FMAU PET/CT
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Multiparametric Magnetic Resonance Imaging	Undergo mpMRI
DEVICE	Positron Emission Tomography	Undergo 18F-FMAU PET/CT
DEVICE	Ultrasound	Undergo TRUS-guided biopsy

Timeline

• Start date: 2016-09-12
• Primary completion: 2021-07-21
• Completion: 2021-07-21
• First posted: 2016-06-22
• Last updated: 2023-09-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study