John Sfakianos, MD, on integrating ctDNA into bladder cancer trials

In this video, John P. Sfakianos, MD, discusses how circulating tumor DNA (ctDNA) could be incorporated into bladder cancer clinical trial designs and treatment strategies. Sfakianos is a professor of urology at the Icahn School of Medicine at Mount Sinai.

Sfakianos highlights the use of ctDNA for risk stratification and treatment selection in the adjuvant setting, citing trials such as IMvigor011 (NCT04660344) and MODERN (NCT05987241) as examples of approaches that use ctDNA status to guide therapy or surveillance. He notes that similar strategies could be explored in other disease settings, including the neoadjuvant setting or high-risk non–muscle-invasive bladder cancer, to identify patients who may benefit from more aggressive treatment.

Standardization of ctDNA assays will also be important as their use expands in clinical trials. Sfakianos discusses the challenges posed by differences among available assays and the difficulty of interpreting results across studies if different platforms are used.

“Unifying and using a single assay will be important, because as we start to shift, then we have unfortunately the bias of the assay that comes in, and we can't cross-interpret from trials,” he explains.

Sfakianos also emphasizes the importance of longitudinal ctDNA monitoring. He suggests obtaining an initial assay at diagnosis followed by repeat testing approximately every 6 weeks to 3 months, depending on disease stage and treatment, to track changes over time.

He noted, “It's not about when we should get it; we should get it at the beginning and then continuously get it and follow those results and make clinical decisions based on how those results change.”