Prostate Cancer Clinical Trial

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

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.

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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.

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Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT02809690

Recruitment Status:

Active, not recruiting

Sponsor:

University of Southern California

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There is 1 Location for this study

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USC / Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States

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Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT02809690

Recruitment Status:

Active, not recruiting

Sponsor:


University of Southern California

How clear is this clinincal trial information?

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