The Impact of Positron Emission Tomography with 18F-Fluciclovine on the Management of Patients with Biochemical Recurrence of Prostate Cancer: Results from the LOCATE Trial

Abstract

PurposeThe prospective, multicenter LOCATE trial assessed the impact of positron emission tomography/computed tomography (PET/CT) with 18F-fluciclovine on management plans for patients with biochemical recurrence (BCR) of prostate cancer after curative-intent primary therapy. Materials and MethodsMen who had undergone curative-intent treatment of histologically confirmed prostate cancer, but who were suspected to have recurrence based on rising prostate-specific antigen (PSA) levels, were enrolled prospectively. Each had negative or equivocal findings on standard-of-care imaging. 18F-Fluciclovine-PET/CT was performed according to standardized protocols. Treating physicians completed a questionnaire regarding the patient’s management plan pre- and post-scan, recording changes to treatment modality (e.g., salvage radiotherapy to systemic androgen deprivation therapy) as ‘major’, and changes within a modality (e.g., modified radiotherapy fields) as ‘other’. ResultsBetween June 2016 and May 2017, 213 evaluable patients (median age 67 years; median PSA 1.00 ng/mL) were enrolled. 18F-Fluciclovine-avid lesions were detected in 122/213 (57%) patients. Overall, 126/213 patients (59%) had a change in management post-scan; 98/126 (78%) of these were ‘major’ and 88/126 (70%) were informed by positive PET/CT findings. The most frequent major changes were from salvage or non-curative systemic therapy to watchful waiting (32/126, 25%), from non-curative systemic therapy to salvage therapy (30/126, 24%) and from salvage therapy to non-curative systemic therapy (11/126, 9%). Conclusion18F-Fluciclovine-PET/CT detected one or more sites of recurrence in the majority of men with BCR, frequently resulting in major changes to their management plans. Future studies will be planned to determine if change of management leads to improved outcomes.