Study Stopped
Slow accrual
18F-FMAU PET/CT in Diagnosing and Characterizing Prostate Cancer
Pilot Feasibility Study of 18F-FMAU PET for Diagnosing and Characterizing Prostate Cancer
4 other identifiers
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2016
CompletedFirst Posted
Study publicly available on registry
June 22, 2016
CompletedStudy Start
First participant enrolled
September 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2021
CompletedSeptember 7, 2023
September 1, 2023
4.9 years
June 19, 2016
September 3, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (1)
Diagnostic (18F-FMAU PET/CT)
EXPERIMENTALPatients 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.
Interventions
Undergo 18F-FMAU PET/CT
Patients receive radiotracer F 18 d-FMAU IV over 1 minute and then undergo 18F-FMAU PET/CT
Undergo mpMRI
Undergo 18F-FMAU PET/CT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hossein Jadvar, MD
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2016
First Posted
June 22, 2016
Study Start
September 12, 2016
Primary Completion
July 21, 2021
Study Completion
July 21, 2021
Last Updated
September 7, 2023
Record last verified: 2023-09