This is a VA study only and will not be put on the SC Research web page.

This study is for subjects with bladder cancer after being treated with BCG and the cancer is currently considered high risk, but not yet reached the bladder muscle. This study is for people who do not qualify for additional BCG treatment or do not want to have their bladder removed. The next line of medication for standard of care treatments with this population are instillations into the bladder with drugs called mitomycin-C or gemcitabine. This study will use a drug delivery system called TAR-200 that slowly releases gemcitabine over 3 weeks. This will be compared to subjects who receive standard of care instillations. Subjects will be randomly assigned (flip of a coin) to either receive standard of care therapy or the study device. The treatment phase will last up to 2 years and the overall study will last up to 5 years.