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P081: Glycosaminoglycan (GAG) scores for surveillance of recurrence in Leibovich Points ≥5 non-metastatic clear cell renal cell carcinoma: AURORAX-0087A trial in progress report

Authors
Dabestani S.1, Azawi N.H.2, Barber N.3, Bex A.4, Campi R.5, Capitanio U.6, Gatto F.7, Giles R.8, Hakimi A.A.9, Järvinen P.10, Karam J.A.11, Ljungberg B.12, Lund L.13, Maddineni S.B.14, Marconi L.15, Master V.16, Minervini A.5, Nielsen T.K.17, Nisen H.10, Rochester M.18, Stewart G.D.19, Nair R.20
Institutions
1Lund University, Skane University Hospital, Dept. of Clinical Sciences Lund, Lund, Sweden, 2Zealand University Hospital, Dept. of Urology, Roskilde, Denmark, 3Frimley Park Hospital, Frimley Renal Cancer Centre, Frimley, United Kingdom, 4Royal Free London NHS Foundation Trust, University College London Division of Surgery and Interventional Science, Specialist Centre for Kidney Cancer, London, United Kingdom, 5AOU Careggi - University of Florence, Dept. of Urology, Florence, Italy, 6IRCCS Ospedale San Raffaele, Dept. of Urology, Milan, Italy, 7Elypta AB, CSO, Stockholm, Sweden, 8International Kidney Cancer Coalition, Patient Representative, Duivendrecht, The Netherlands, 9Memorial Sloan Kettering Cancer Center, Dept. of Surgery, Urology Service, New York, United States of America, 10Helsinki University Central Hospital, Dept. of Urology, Helsinki, Finland, 11The University of Texas M.D. Anderson Cancer Center, Dept. of Urology, Houston, United States of America, 12Umeå University, Dept. of Surgical and Perioperative Sciences, Urology and Andrology, Umeå, Sweden, 13University of Southern Denmark, Dept. of Urology and Dept. of Clinical Research, Odense, Denmark, 14Salford Royal NHS Foundation Trust, The Christie NHS Foundation Trust, Dept. of Urology, Salford, United Kingdom, 15Coimbra University Hospital, Dept. of Urology, Coimbra, Portugal, 16Emory University School of Medicine, Dept. of Urology, Atlanta, United States of America, 17Aarhus University Hospital, Dept. of Urology, Aarhus, Denmark, 18Norfolk and Norwich University Hospital, Dept. of Urology, Norwich, United Kingdom, 19University of Cambridge, Addenbrooke’s Hospital, Dept. of Surgery, Cambridge Biomedical Campus, Cambridge, United Kingdom, 20Guy's and St Thomas' NHS Foundation Trust, Dept. of Urology, London, United Kingdom
Event
EMUC20 - 12th European Multidisciplinary Congress on Urological Cancers (EMUC20)
Date
13 November 2020
Topic
Renal Cell Carcinoma - Follow up

Introduction & Objectives

Non-metastatic clear cell renal cell carcinoma (ccRCC) recurs within 5 years in about 20% of cases after curative intent surgery. Current postoperative follow-up protocols, being imaging-based and at best built on risk of recurrence scores, are not optimised for early detection of recurrence. Glycosaminoglycans (GAGs) profiles in blood and urine represent a new type of diagnostic biomarkers, whose measurements can be aggregated in three so called GAG scores - blood, urine, and combined. GAG scores have accurately distinguished localised/locally-advanced and advanced renal cell carcinoma (RCC) from healthy subjects. To further evaluate the potential of GAG scores in the detection of ccRCC recurrence after curative intent surgery, a European Union Horizon 2020 funded (grant number 849251) multinational clinical trial has been initiated: AURORAX-0087A (AUR87A; ClinicalTrials.gov ID: NCT04006405). The aim of this publication is to provide a trial in progress report.

Materials & Methods

AUR87A, a sponsor driven trial, is designed to prospectively enroll an estimated 280 non-metastatic ccRCC patients curatively treated with surgery (partial or radical nephrectomy) with intermediate to high risk of recurrence (Leibovich Points ≥5). Enrolled subjects are to be follow-up for a minimum 12 months and up to 18 months, with blood and urine sampling preoperatively and every 3 months for GAG score assessment, this alongside the current standard of care follow-up protocols, i.e. imaging, as comparator for recurrence detection. The primary endpoint is to be sensitivity and specificity analyses of GAG score to detect a recurrence compared to reference standard (imaging).

Results

AUR87A was initiated in December 2019. Of the 16 sites (13 located in Europe and 3 in the US) involved in the study, 15 have received ethical approval, site staff training and are currently enrolling. First patient first visit was registered on January 4th 2020, and first patient enrolled on February 5th. Cumulatively to date, the study has consented and recruited 86 subjects. Of these, 19 subjects were found to be eligible at postoperative final screening and are now actively enrolled in the follow-up phase. Overall, 14% of the enrollment target for initial cohort has been met thus far.

Conclusions

AUR87A, a trial to determine the diagnostic accuracy of GAG scores to detect ccRCC recurrence during follow-up is well underway. An interim analysis at 15 recurrences is planned for 3rd quarter of 2021 to assess the current sensitivity and specificity estimates of GAG scores and AUR87A is expected to reach study end in 2nd quarter of 2022.

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