The BladderPath randomized control trial aims to compare risk-stratified image directed care with TURBT for patients with a new diagnosis of bladder cancer.
For this trial, eligible patients were those undergoing cystoscopy for symptoms suggesting bladder cancer in whom suspicious lesions were identified and required TURBT procedure. According to the cystoscopy appearance, patients were stratified by a 5-point Likert scale into 1) strongly agree or 2) agree that the lesion is not-muscle-invasive bladder cancer, 3) equivocal or 4) agree or 5) strongly agree the lesion is muscle-invasive bladder cancer.
Patients were randomized to standard of care (TURBT) or to stratified multi-parametric MRI directed care (for Likert score 1-2 patients would undergo TURBT, and for Likert score 3-5 – patients would undergo mpMRI using the PI-RADS protocol, and flexible cystoscopy guided tissue biopsy under local anesthesia), as shown in Figure 1.
Figure 1. Trial schema
The authors reported that so far 258 patients were screened, and 96 patients were recruited, of which 67 have completed staging and are described in this presentation. Table 1 demonstrates the demographics of the patients recruited so far.
Table 1. Patient characteristics
Results showed that of the 31 patients in pathway one (TURBT) - 16 were classified as probable non-muscle invasive bladder cancer and all 16 did end up having non-muscle invasive bladder cancer on TURBT. 15 patients were diagnosed as possible muscle-invasive bladder cancer (with 9 eventually having non-muscle-invasive bladder cancer, and 5 having muscle-invasive bladder cancer, with one patient undergoing multiparametric MRI by mistake).
Of the 36 patients in pathway 2 (mpMRI), 17 were classified as probable non-muscle-invasive bladder cancer of which 15 underwent TURBT (13 having NMIBC and 2 having MIBC). The additional 19 patients were classified as possible muscle-invasive bladder cancer, of which 18 underwent multiparametric MRI (10 having NMIBC and 8 having MIBC). These data are summarized in Figure 2.
Figure 2. Flor of patients through the study
The authors concluded that further work is required to ascertain whether multiparametric MRI can be used instead of TURBT for the staging of bladder cancer.
Presented by: Nicholas James, PhD, MBBS, FRCP, University of Birmingham, UK
Written by: Hanan Goldberg, MD, Urology Department, SUNY Upstate Medical University, Syracuse, New York, Twitter: @GoldbergHanan at the 2020 Genitourinary Cancers Symposium, ASCO GU #GU20, February 13-15, 2020, San Francisco, California