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

Prostate Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02809690
• Other study ID #: 4P-16-3
• Secondary ID: NCI-2016-008144P
• Status: Terminated
• Phase: Phase 1
• Start date: September 12, 2016
• Est. completion date: July 21, 2021

Study information

• Verified date: September 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: July 21, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

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
• Ultrasound
Undergo TRUS-guided biopsy

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Standard descriptive methods will be used to summarize the data collected: means, standard deviations, ranges, and confidence intervals (or medians, quartiles), contingency tables, histograms, correlation coefficients (Pearson or Spearman) and scatter plots. The scatter plots and correlations between each of the histopathology parameters and the imaging parameters will be examined to better understand the relationships.	Up to 1 year
Primary	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	Standard descriptive methods will be used to summarize the data collected: means, standard deviations, ranges, and confidence intervals (or medians, quartiles), contingency tables, histograms, correlation coefficients (Pearson or Spearman) and scatter plots. The scatter plots and correlations between each of the histopathology parameters and the imaging parameters will be examined to better understand the relationships.	Up to 1 year
Primary	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	Standard descriptive methods will be used to summarize the data collected: means, standard deviations, ranges, and confidence intervals (or medians, quartiles), contingency tables, histograms, correlation coefficients (Pearson or Spearman) and scatter plots. The scatter plots and correlations between each of the histopathology parameters and the imaging parameters will be examined to better understand the relationships.	Up to 1 year