ASCO GU 2018: The FALCON Trial: Impact of 18F-fluciclovine PET/CT on Clinical Management Choices for Men with Biochemically Recurrent Prostate Cancer

San Francisco, CA ( Detection of the extent of local recurrence and of metastases in biochemical recurrence (BCR) of prostate cancer (PC) facilitates selection of appropriate treatment. The FALCON trial assessed the impact of 18F-fluciclovine PET/CT on the clinical management of men with PC BCR following initial radical therapy.

Men being considered for curative-intent salvage therapy following BCR were recruited at 6 different UK sites. Management plans were documented prior to and following 18F-fluciclovine PET/CT imaging. Treatment changes made after the scans were stratified as either “major” (changes to treatment modality such as salvage radiotherapy [RT] to systemic therapy), or “other” (changes within a modality such as modified RT fields). A pre-planned interim analysis of the first 85 patients was conducted; recruitment was to be stopped for efficacy if the number of treatment changes was > 45 (52.9%; 97.5% CI: 40.3–62.3%), or for futility if ≤ 8 (9.4%, 97.5% CI: 3.6–18.9%).

The 85 enrolled patients were with a mean 4.8 y post-initial diagnosis, with a median age of 67 years, and with a median PSA of 0.63 ng/mL. Twelve (14.1%) had a Gleason score ≤ 6, 60 (70.6%) had a score of 7 and 13 (15.3%) had a score ≥ 8. A total of 56/85 (65.9%) had previously undergone radical prostatectomy (RP), with 27 having received RT (± other therapy). The majority of those imaged (52; 61.2%) had a post scan change in management (CIM), as can be seen in Figure 1. As a result, recruitment was stopped as the pre-specified condition defining overwhelming efficacy was met.

This prospective trial demonstrates that 18F-fluciclovine PET/CT has substantial impact on clinical decisions for men with PC BCR after curative-intent primary therapy. Clinical trial information: NCT02578940

Figure 1 – Changes in management results:


Presented by: Eugene Jueren Teoh, MBBS, MRCP, Department of Oncology, University of Oxford

Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre @GoldbergHanan at the 2018 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, February 8-10, 2018 - San Francisco, CA

Read More Related Content:
Blue Earth Diagnostics’ Initial Results from FALCON Trial Show 61% of Patients with Suspected Recurrent Prostate Cancer had Treatment Plan Changed Following Fluciclovine (18F) PET/CT Scan