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
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