Phase 2
N=61
Validation of FACBC for Detection of Metastasis Among High-risk Prostate Cancer Patients With Presumed Localized Disease
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03081884 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Cancer Detection Performance of FACBC PET/CT — 17; 22; 4; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- FACBC PET-CT Imaging (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Emory University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cancer Detection Performance of FACBC PET/CT |
17; 22; 4; 14 | — |
| SECONDARY Diagnostic Performance of FACBC PET/CT and Conventional Imaging |
55.3; 33.3; 84.8; 84.1; 81.5; 72.2 | — |
Summary
This study is for patients who have a high risk of metastatic prostate cancer (cancer that has spread outside of the prostate) who are going to have radical prostatectomy. The Anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC or Fluciclovine) positron emission tomography (PET) scan is a new imaging approach that has promising results in showing progression of cancer. The goal of this study is to determine if FACBC PET imaging will detect metastatic disease in patients with high risk prostate cancer who have negative conventional cross-sectional imaging such as computed tomography (CT) and/or magnetic resonance imaging (MRI), as well as bone scan and/or sodium fluoride PET. FACBC PET imaging may help detect metastatic prostate cancer in patients with newly diagnosed high risk primary prostate cancer and potentially improve staging of the cancer. Additionally, the researchers will compare the FACBC uptake in the prostate with uptake of FACBC detected in metastasis. They will also analyze and compare the prostate tissue, serum and urine parameters that are linked to higher rates of FACBC positivity.
Eligibility Criteria
Inclusion Criteria
- High-risk prostate cancer patients eligible for standard of care surgery
- At least clinical T3a disease, and/or Gleason≥8, and/or Prostate-Specific Antigen (PSA) >20, as per clinical assessment and routine guidelines
- Undergone standard of care conventional imaging (CT and/or MRI; bone scan and/or sodium fluoride (NaF) PET)
Exclusion Criteria
- Definitive findings of systemic metastasis on conventional imaging.
Data sourced from ClinicalTrials.gov (NCT03081884). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.