The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients
treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior
event-free survival (EFS) compared to standard treatment with intravesical BCG. The purpose
of this study is to test whether Gemcitabine + Docetaxel is a better or worse treatment than
the usual BCG therapy approach. The primary objective of this study is to determine the event
free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients
treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as
follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline
to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to
determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated
with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of
BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to
determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with
intravesical BCG vs GEMDOCE.