Dr Kato on the MONSTAR-Screen-3 Study in Resectable RCC

“We believe that our approach is feasible and that it may be [used to] predict [disease] recurrence.”

Taigo Kato, MD, PhD, an assistant professor in the Department of Urology at Osaka University Graduate School of Medicine, discussed the MONSTAR-SCREEN-3 study (UMIN000053975) evaluating an ultra-sensitive whole genome sequencing-based minimal residual disease (MRD) assay in patients with resectable renal cell carcinoma (RCC).

Circulating tumor DNA (ctDNA) has previously been shown to be a promising biomarker for post-surgical MRD detection, Kato began. However, limited data are available in terms of its utility in low shedding tumors such as RCC, he continued.

MONSTAR-SCREEN-3 was a prospective, multicenter study that evaluated a platform that combined spatial transcriptomics with circulating tumor DNA/RNA sequencing, bulk tissue whole exome/transcriptome sequencing, plasma proteomics, and microbiome analyses. A total of 3200 patients were screened in the study, including 1100 with resectable/radically curable solid tumors. The definitive cohort of MONSTAR-SCREEN-3 included patients with gastrointestinal, hepato-pancreato-biliary, breast, gynecological, urological, head and neck, melanoma and skin, and other cancer types, as well as those with sarcoma.

Preliminary findings from MONSTAR-SCREEN-3 presented by Kato during the 2026 Genitourinary Cancers Symposium revealed that the whole genome sequencing approach used in MONSTAR-SCREEN-3 produced robust detection capabilities in patients with RCC (n = 29). Specifically, the baseline sensitivity rate was 100% and at 1-month post-surgery, the MRD positivity rate was 11.1%, Kato explained. Moreover, 50.0% of positive cases were detected at ultra-sensitive levels, he added. ctDNA levels were associated with tumor stage, size, and nodal status, he noted.

The approach was found to be feasible and could prove useful in terms of aiding in disease recurrence prediction in RCC, Kato concluded. The study authors noted that additional validation with extended follow-up and an expanded cohort is necessary to confirm their findings.

Disclosures: Kato received honoraria from Bristol-Myers Squibb Japan; Merck; MSD; Pfizer; Takeda. He also received research funding from Takeda.