Clinical trial NCT02809690: 18F-FMAU PET/CT in Diagnosing and Characterizing Prostate Cancer
Official title: Pilot Feasibility Study of 18F-FMAU PET for Diagnosing and Characterizing Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Prostate Neoplasm
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2016-06-22
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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

Primary outcomes:
measure: Proportion of men for whom biopsy cores taken based only on the 18F-FMAU PET/CT results would have yielded the same overall diagnosis as the standard TRUS-guided core or the mpMRI-directed prostate biopsies
timeFrame: Up to 1 year
measure: Proportion of men for whom the 18F-FMAU PET/CT identified all lesions that were found to have cancer based on the standard TRUS-guided and the mpMRI directed core prostate biopsies
timeFrame: Up to 1 year
measure: Proportion of men who completed both imaging procedures and for whom biopsy cores taken based only on the fluorine 18F-FMAU PET/CT results would have yielded the same overall diagnosis as the standard TRUS-guided core prostate biopsies
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Hossein Jadvar, MD
role: PRINCIPAL_INVESTIGATOR
References: