Retrospective Observational Study Investigating Fluciclovine (18F) (FACBC)

Study Overview
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Brief Summary
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This retrospective observational multi centered study has been established to collect the clinical experience relating to the administration of Fluciclovine 18F employed in both investigator initiated studies and named patient/compassionate use programmes in up to 5 sites.

Detailed Description
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This study will collect clinical data from consenting patients (unless a HIPAA waiver or equivalent was granted) who received the PET radiotracer Fluciclovine 18F (FACBC) (a synthetic amino acid analog) for imaging of patients with various cancers at participating sites in the US and Europe. Data collection will cover baseline medical history and medications in all patients. The result of PET radiotracer and other imaging findings, and reports of histopathology from biopsied tissue (where available) and in a time window relevant to the use of PET imaging in the diagnosis of primary/recurrent prostate cancer will be recorded. In all subjects, with regards to safety monitoring, available data for physical examination, vital signs and laboratory test results will be collected from 28 days prior to and out to a 35 day window after Fluciclovine 18F (FACBC) administration. The major goals of the investigation are to consolidate the safety profile of Fluciclovine 18F (FACBC), to evaluate its use in the detection of local and extraprostatic recurrence of prostate cancer and to evaluate its ability to detect malignancy in patients undergoing screening for primary prostate cancer.

Official Title
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A Retrospective Observational Study Investigating the Safety and Effectiveness of Fluciclovine (18F) (FACBC) PET Ligand in Human Subjects

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Radiation: Fluciclovine (18F)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient managed by a site at which ethical committee approval for retrospective data collection under this protocol has been received Patient has received at least one injection of fluciclovine (18F) for the detection of a malignant tumour at any location Exclusion Criteria: Subjects will be excluded from the analyses if any of the following criteria are met: Patients participating in clinical trials or open access programmes at countries or sites not participating in this study. Patients managed at sites without ethical committee approval for retrospective data collection under this protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Fluciclovine (18F)|Not applicable. This is an observational study.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events | Treatment-emergent Adverse Events and Treatment-Emergent Serious Adverse Events | Up to 35 days post Fluciclovine 18F | 
| Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer | Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy. | Up to 1 year post Fluciclovine 18F | 
| Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer | Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy. | Up to 1 year post Fluciclovine 18F | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer | Detection rate is the percentage of participants with positive finding in Fluciclovine 18F scan. Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan. Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan. Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy. | Up to 1 year post Fluciclovine 18F | 
| Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer | Detection rate is the percentage of participants with positive finding in Fluciclovine 18F scan. Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan. Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan. Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy. | Up to 1 year post Fluciclovine 18F | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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observational study