Oncologic outcomes of radical cystectomy versus trimodal therapy in management of localized muscle-invasive urothelial bladder cancer: A prospective randomized clinical trial

Objectives Radical cystectomy (RC) is the conventional standard treatment of muscle-invasive bladder cancer (MIBC), while trimodal therapy (TMT) offers a bladder-sparing alternative. To date, data directly comparing both modalities are still limited. We aimed at comparing the oncological outcomes and survival rates associated with both approaches.Methods This prospective clinical trial initially enrolled 73 patients with cT2N0M0 urothelial MIBC eligible for both treatment strategies. Cases were randomized to RC and TMT and were followed up for 3 years. Clinical characteristics, disease-free survival (DFS), cancer-specific survival (CSS) and overall survival (OS) were compared.Results Of 73 patients initially enrolled in the study, 54 were included in the per-protocol analysis of whom 27 underwent RC and 27 received TMT. Baseline clinical characteristics were similar across groups. At 3 years, the rates of local recurrence and distant metastasis were higher in TMT group than the RC group (51.9 vs 7.4% and 29.6 vs 7.4%, respectively, p < 0.01). RC showed an improved DFS with a median of 36 months as compared to 21 months for TMT (p = 0.01). RC showed initial reduced rates of 1-year CSS and OS compared to TMT. Later, RC demonstrated higher CSS and OS. However, by 3 years, the difference in survival was not statistically significant.Conclusions RC offers superior disease control compared to TMT, while survival remains comparable at 3 years in selected cT2N0M0 bladder cancer patients.Institutional Review Board approval number FMASU MD 183/2022Clinical trial registration number NCT07043790 https://clinicaltrials.gov/study/NCT07043790