N/A
Completed N=714
Retrospective Observational Study Investigating Fluciclovine (18F) (FACBC)
Source: ClinicalTrials.gov NCT02443571 ↗Enrolled (actual)
714
Serious AEs
0.3%
Results posted
Oct 2018
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events — 32; 2; 8; 1 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events |
32; 2; 8; 1; 1; 0 | — |
| PRIMARY Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer |
82.4; 92.3; 71.8 | — |
| PRIMARY Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer |
100 | — |
| SECONDARY Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer |
82.4; 94.7; 54.8; 77.3 | — |
| SECONDARY Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer |
93.4; 93.4 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02443571). 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. Informational only — not medical advice.