FALCON
A PET scan using the tracer fluciclovine (brand Axumin) was tested in UK men whose prostate cancer PSA had risen again, to see how often the scan changed the treatment doctors planned to give.
Overview
FALCON was a UK-based, prospective, multicentre, open-label phase 3 trial of 18F-fluciclovine PET-CT (Axumin) jointly funded by Innovate UK and Blue Earth Diagnostics, run across six NHS sites. It enrolled men with a first episode of biochemical recurrence after curative-intent therapy who were being considered for salvage treatment. The primary endpoint was the proportion of patients whose documented management plan changed after the scan, comparing pre-scan and post-scan plans recorded by treating clinicians.
Among 104 scanned patients (median PSA 0.79 ng/mL), lesions were detected in 56%, with detection rising with PSA. A management change occurred in 64% (66/104) of patients, 65% of these classed as major (a change in treatment modality, such as salvage or systemic therapy to watchful waiting, or vice versa); the remainder were adjustments within a modality, commonly a fluciclovine-guided radiotherapy boost. A pre-planned interim analysis stopped recruitment early on efficacy grounds. A related secondary analysis found that outcomes tended to be better when salvage therapy was guided by a positive scan.
FALCON, alongside the US LOCATE trial, supported the clinical adoption of fluciclovine PET for biochemical recurrence, and its subgroup work on salvage radiotherapy planning fed into later evidence (including a separate randomised trial) showing improved failure-free survival when radiotherapy fields were guided by fluciclovine PET rather than conventional imaging.
- 64 out of 100 people reached this endpoint with 18F-fluciclovine PET-CT.
- 66/104; recruitment stopped early for overwhelming efficacy at a planned interim analysis.
- 56 out of 100 people reached this endpoint with 18F-fluciclovine PET-CT.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Men with a first episode of biochemical recurrence of prostate cancer after curative-intent primary therapy, being considered for salvage therapy; a diagnostic (management-impact) trial. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
104 enrolled.
66/104; recruitment stopped early for overwhelming efficacy at a planned interim analysis
Source58/104 patients had at least one avid lesion; 93% of scans positive at PSA >2.0 ng/mL
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Proportion of patients with a revised management plan (pre-scan vs post-scan)primary | 18F-fluciclovine PET-CT | 104 | 64% | - | - | link |
| Detection rate | 18F-fluciclovine PET-CT | 104 | 56% | - | - | - |
Similar pages
not linked directly; found by shared links- TrialSPOTLIGHT
Shares Blue Earth Diagnostics (Bracco), Biochemical recurrence of prostate cancer, Fluorine-18 and the tags diagnostic trial, prostate cancer, biochemical recurrence.
- TrialCONDOR
Shares Biochemical recurrence of prostate cancer, Fluorine-18 and the tags diagnostic trial, prostate cancer, biochemical recurrence.
- CompanyBracco Imaging
Shares Fluciclovine F-18, Blue Earth Diagnostics (Bracco), Fluorine-18.
- Trial[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
- TrialLIGHTHOUSE
Shares Blue Earth Diagnostics (Bracco), Fluorine-18 and the tags diagnostic trial, prostate cancer.
- TrialOSPREY
Shares Fluorine-18 and the tags diagnostic trial, prostate cancer.
- AgentFlotufolastat F-18
- TermBiochemical recurrence (BCR)
Shares Fluciclovine F-18, Fluorine-18.