Randomized Comparison of Magnetic Resonance Imaging Versus Transurethral Resection for Staging New Bladder Cancers: Results From the Prospective BladderPath Trial
Richard T. Bryan, Wenyu Liu, Sarah Pirrie, Rashid Amir, Jean Gallagher, Ana Hughes, Kieran Jefferson, Allen Knight, Veronica Nanton, Harriet P. Mintz, Ann Pope, Jacob Cherian, Kingsley Ekwueme, Lyndon Gommersall, Giles Hellawell, Paul Hunter-Campbell, Gokul Kanda Swamy, Sanjeev Kotwal, Vivekanandan Kumar, David Mak, Amar Mohee, Thiagarajan Nambirajan, Douglas G. Ward, Steven Kennish, James W.F. Catto, Prashant Patel, Nicholas D. James, on behalf of the BladderPath Collaborative Group, Douglas G. Ward, Naheema S. Gordon, Sarah Pirrie, Sophia Magwaro, Ann Pope, Ana Hughes, H. Doyle, Jacob Cherian, Lyndsay Scarratt, Dawn Johnstone, Denise Hadfield, Amy Slack, Kingsley Ekwueme, Amanda Jones, Bethan Wyn Owen, Lyndon Gommersall, Mark Kitchen, Michelle Davies, Vinodh Murali, Giles Hellawell, P. Gurung, Paul Hunter-Campbell, Lyn Cogley, Gokul Kanda Swamy, Ellen Turrell, Maria Johnstonem, James W.F. Catto, Steven Kennish, Aidan P. Noon, Marcus Cumberbatch, Derek J. Rosario, Louise Goodwin, Katharine Behennah, Ferekh Salim, Syed A. Hussain, Sanjeev Kotwal, Christopher J. Main, Vivekanandan Kumar, Mark A. Harmer, David Mak, William J. Taylor, Baljinder Rai, Amar Mohee, Hosam A Noweir, Houda Chea, Thiagarajan Nambirajan, Nina Patrick, Vandan Arora, Ya-Wen Jessica Huang, Prashant Patel, Amar Manandhar, Rosie Henvey, Kieran Jefferson, Davina Hewitt, Anthony Blacker, Donald Macdonald, James Harding, Yakhub Khan, Altan Omer, Andrew Chan, Diokno Michael, Nicholas D. James, Bernard Sui, Josh Shur, Vincent Khoo
Abstract
PURPOSE Transurethral resection of bladder tumor (TURBT) is the initial staging procedure for new bladder cancers (BCs). For muscle-invasive bladder cancers (MIBCs), TURBT may delay definitive treatment. We investigated whether definitive treatment can be expedited for MIBC using flexible cystoscopic biopsy and multiparametric magnetic resonance imaging (mpMRI) for initial staging. PATIENTS AND METHODS We conducted a prospective open-label, randomized study conducted within 17 UK hospitals (registered as ISRCTN 35296862). Participants with suspected new BC were randomly assigned 1:1 to TURBT-staged or mpMRI-staged care, with minimization factors of sex, age, and clinician visual assessment of stage. Blinding was not possible. Patients unable/unwilling to undergo mpMRI or with previous BC were ineligible. The study had two stages with separate primary outcomes of feasibility and time to correct treatment (TTCT) for MIBC, respectively. RESULTS Between May 31, 2018, and December 31, 2021, 638 patients were screened, and 143 participants randomly assigned to TURBT (n = 72; 55 males, 15 MIBCs) or initial mpMRI (n = 71; 53 males, 14 MIBCs). For feasibility, 36 of 39 (92% [95% CI, 79 to 98]) participants with suspected MIBC underwent mpMRI. The median TTCT for participants with MIBC was significantly shorter with initial mpMRI (n = 12, 53 days [95% CI, 20 to 89] v n = 14, 98 days [95% CI, 72 to 125] for TURBT, log-rank P .02). There was no detriment for participants with non-MIBC (median TTCT: n = 30, 17 days [95% CI, 8 to 25] for mpMRI v n = 28, 14 days [95% CI, 10 to 29] for TURBT, log-rank P = .67). No serious adverse events were reported. CONCLUSION The mpMRI-directed pathway led to a 45-day reduction in TTCT for MIBC. Incorporating mpMRI ahead of TURBT into the standard pathway was beneficial for all patients with suspected MIBC.