Effect of 18F-Fluciclovine Positron Emission Tomography on the Management of Patients With Recurrence of Prostate Cancer: Results From the FALCON Trial.

Early and accurate localization of lesions in patients with biochemical recurrence (BCR) of prostate cancer may guide salvage therapy decisions. The present study, 18F-Fluciclovine PET/CT in biochemicAL reCurrence Of Prostate caNcer (FALCON; NCT02578940), aimed to evaluate the effect of 18F-fluciclovine on management of men with BCR of prostate cancer.

Men with a first episode of BCR after curative-intent primary therapy were enrolled at 6 UK sites. Patients underwent 18F-fluciclovine positron emission tomography/computed tomography (PET/CT) according to standardized procedures. Clinicians documented management plans before and after scanning, recording changes to treatment modality as major and changes within a modality as other. The primary outcome measure was record of a revised management plan postscan. Secondary endpoints were evaluation of optimal prostate specific antigen (PSA) threshold for detection, salvage treatment outcome assessment based on 18F-fluciclovine-involvement, and safety.

18F-Fluciclovine was well tolerated in the 104 scanned patients (median PSA = 0.79 ng/mL). Lesions were detected in 58 out of 104 (56%) patients. Detection was broadly proportional to PSA level; ≤1 ng/mL, 1 out of 3 of scans were positive, and 93% scans were positive at PSA >2.0 ng/mL. Sixty-six (64%) patients had a postscan management change (80% after a positive result). Major changes (43 out of 66; 65%) were salvage or systemic therapy to watchful waiting (16 out of 66; 24%); salvage therapy to systemic therapy (16 out of 66; 24%); and alternative changes to treatment modality (11 out of 66, 17%). The remaining 23 out of 66 (35%) management changes were modifications of the prescan plan: most (22 out of 66; 33%) were adjustments to planned brachytherapy/radiation therapy to include a 18F-fluciclovine-guided boost. Where 18F-fluciclovine guided salvage therapy, the PSA response rate was higher than when 18F-fluciclovine was not involved (15 out of 17 [88%] vs 28 out of 39 [72%]).

18F-Fluciclovine PET/CT located recurrence in the majority of men with BCR, frequently resulting in major management plan changes. Incorporating 18F-fluciclovine PET/CT into treatment planning may optimize targeting of recurrence sites and avoid futile salvage therapy.

International journal of radiation oncology, biology, physics. 2020 Feb 14 [Epub]

Andrew F Scarsbrook, David Bottomley, Eugene J Teoh, Kevin M Bradley, Heather Payne, Asim Afaq, Jamshed Bomanji, Nicholas van As, Sue Chua, Peter Hoskin, Anthony Chambers, Gary J Cook, Victoria S Warbey, Sai Han, Hing Y Leung, Albert Chau, Matthew P Miller, Fergus V Gleeson, FALCON study group

Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom; University of Leeds, Leeds, United Kingdom. Electronic address: ., Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom., Blue Earth Diagnostics, Oxford, United Kingdom., PETIC, Wales Research and Diagnostic PET Imaging Centre, Cardiff, United Kingdom., University College London Hospitals, NHS Foundation Trust, London, United Kingdom., The Royal Marsden NHS Foundation Trust, London, United Kingdom., Mount Vernon Cancer Centre, London, United Kingdom., King's College London and Guy's & St Thomas' PET Centre, St Thomas' Hospital, London, United Kingdom., West of Scotland PET Centre, Gartnavel General Hospital, Glasgow, United Kingdom., Institute of Cancer Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom; CRUK Beatson Institute, Glasgow, United Kingdom., Departments of Radiology and Nuclear Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.

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