{"entity":{"id":"falcon","kind":"trial","name":"FALCON","aka":["18F-fluciclovine biochemical recurrence management trial"],"tldr":"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.","summary":"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.\n\nAmong 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.\n\nFALCON, 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.","status":"completed","asOf":"2026-09-22","links":[{"label":"Int J Radiat Oncol Biol Phys 2020: FALCON primary results (Scarsbrook et al.)","url":"https://pubmed.ncbi.nlm.nih.gov/32068113/"},{"label":"ClinicalTrials.gov: NCT02578940","url":"https://clinicaltrials.gov/study/NCT02578940"},{"label":"Blue Earth Diagnostics: FALCON trial results announcement","url":"https://www.blueearthdiagnostics.com/hubfs/PR063.pdf"}],"tags":["diagnostic trial","prostate cancer","biochemical recurrence","management impact"],"related":["fluciclovine-f18","prostate-bcr","blue-earth-diagnostics","f-18"],"indications":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02578940","phase":"3","setting":"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","sponsor":"Blue Earth Diagnostics","result":"64% (66/104) of patients had a management plan change after 18F-fluciclovine PET-CT, 65% of those major (e.g. a switch in treatment modality); lesions were detected in 56% of scans (Scarsbrook et al., Int J Radiat Oncol Biol Phys 2020)","yearReported":2019,"enrolled":104,"enrolledBasis":"registry","outcomes":[{"endpoint":"Proportion of patients with a revised management plan (pre-scan vs post-scan)","primary":true,"unit":"%","arms":[{"name":"18F-fluciclovine PET-CT","n":104,"value":64,"note":"66/104; recruitment stopped early for overwhelming efficacy at a planned interim analysis"}],"source":"https://pubmed.ncbi.nlm.nih.gov/32068113/"},{"endpoint":"Detection rate","unit":"%","arms":[{"name":"18F-fluciclovine PET-CT","n":104,"value":56,"note":"58/104 patients had at least one avid lesion; 93% of scans positive at PSA >2.0 ng/mL"}]}]},"route":"/trials/falcon/","neighbours":{"drug":[{"id":"fluciclovine-f18","kind":"drug","name":"Fluciclovine F-18","route":"/drugs/fluciclovine-f18/"}],"indication":[{"id":"prostate-bcr","kind":"indication","name":"Biochemical recurrence of prostate cancer","route":"/indications/prostate-bcr/"}],"company":[{"id":"blue-earth-diagnostics","kind":"company","name":"Blue Earth Diagnostics (Bracco)","route":"/companies/blue-earth-diagnostics/"}],"isotope":[{"id":"f-18","kind":"isotope","name":"Fluorine-18","route":"/isotopes/f-18/"}]}}