31: AURORAX-0087A: Glycosaminoglycan (GAG) scores for recurrence detection in Leibovich Points ≥5 clear cell renal cell carcinoma - Trial In Progress

Viraj Master, MD, PhD; Rachel Giles, MD, PhD; Lorenzo Marconi, MD, PhD; Andrea Minervini, MD, PhD; Axel Bex , MD, PhD; Nessn Azawi, MD, PhD ; Neil Barber, MD, PhD ; Börje Ljungberg, MD, PhD ; Lars Lund, MD, PhD ; Harry Nisen, MD, PhD ; Ari Hakimi, MD, PhD ; Satish Maddineni, MD, PhD ; Tommy Nielsen, MD, PhD ; Riccardo Campi, MD, PhD ; Umberto Capitanio, MD, PhD ; Petrus Järvinen, MD, PhD ; Jose Karam, MD, PhD ; Rajesh Nair, MD, PhD ; Mark Rochester, MD, PhD ; Grant Stewart, MD, PhD ; Francesco Gatto, PhD

Background: About 20% of patients who undergo curative surgery for non-metastatic clear cell renal cell carcinoma (M0 ccRCC) recur within 5 years. Current follow-up guidelines using regular interval imaging are not optimized for early detection of recurrence. In a prospective single-center cohort study exploring a new type of liquid biopsy based on free glycosaminoglycan profiles (GAGome) as biomarkers of RCC metabolism, found the free GAGome score in urine to have 81% sensitivity 83% specificity to M0 RCC recurrence. We initiated the prospective multicenter cohort study AURORAX-0087A (AUR87A; NCT04006405) to validate the clinical use of the urine free CS recurrence score in the surveillance of ccRCC recurrence after surgery.

Methods: Currently active in 26 sites across Europe, US, and Canada, AUR87A is enrolling M0 ccRCC patients curatively treated with nephrectomy, at intermediate to high risk of recurrence (Leibovich Points ≥5). After surgery, patients are followed-up according to standard of care protocols for a minimum of 12 months; GAG scores from biospecimen samples, collected preoperatively and every 3 months post-surgery, are compared to standard of care imaging for recurrence detection. The primary endpoint is the sensitivity and specificity of urine free CS recurrence score. As of January 2022, over 430 patients have been screened for eligibility, of which 144 are eligible for the study. Enrollment of the validation Cohort 1 is complete; an interim analysis in 2022 will assess the GAG score sensitivity and specificity estimates; enrollment of Cohort 2 is ongoing. AUR87A is the first multicenter prospective study to validate the diagnostic performance of a liquid biomarker in RCC. Study end is expected in 2nd quarter of 2023.

AUR87A is funded by European Union Horizon 2020 grant number 849251.