A randomized trial comparing fluorocholine-PET/CT with conventional imaging in prostate cancer.

• DOI: 10.1200/jco.2019.37.7_suppl.2
• Publication Date: 2019-03-07T21:20:31Z
• Authors: Scott Williams; Jean-Mathieu Beau...; Peter Roselt; Kate Moody; Richard Fisher; Elizabeth Drummond; Rodney J Hicks
• Keywords: Clinical endpoint

2 Background: We conducted a randomised trial comparing 18 Flourocholine-PET/CT (FCH) to Computed Tomography (abdomen and pelvis) plus 99m Tc-Whole Body Bone Scan (Conventional Imaging [CIm]) determine imaging performance in prostate cancer (PC). Methods: This prospective two-arm 1:1 enrolled men with newly diagnosed or biochemically recurrent PC first-line (FLI) either CIm FCH. Participants without evidence of metastases proceeded second-line (SLI) using the alternative strategy. The primary aim was whether FCH more effective as FLI approach changing management. Secondary endpoints included incremental utility SLI negative predictive value (NPV) based on progression-free survival (PFS). Australian New Zealand Clinical Trials Registry ACTRN12608000641392. Results: 108 were enrolled; 44% for staging newly-diagnosed median follow-up 43 months. impacted clinical management 32.4% (95% CI=23.7-42.1%), mostly (n=30). High-impact changes occurred 27.8% CI=16.5-41.6%) cases compared 11.1% CI=4.2-22.6%) arm (p=0.032). final plan derived 98.1% CI = 90.1-100%) 92.6% (95%CI 82.1-97.9%) (p=0.242). showed unequivocally N1 M1 disease 22.2% 12-35.6%), 16.7% 7.9-29.3%; p= 0.531) cases. overall NPV stage TxN0M0 (from all imaging) 26.3% CI: 13.9 - 41.2%), no significant difference between arms (p=0.9). For N1M0 cases, 14.3% 7.1 35.7%). identification by resulted longer time progressive disease, PFS 32 months CI=2-68months) 3 CI=1-16 months) cohort (p=0.05). Conclusions: FCH-PET/CT identifies high-clinical-impact lesions than imaging. All modalities poor at predicting subsequent disease. Isolated node-positive seen is associated but similarly high rates recurrence, suggesting lead-time bias. information: