Patients with bladder cancer often have to choose between surgical removal of their bladder or a three-year course of the immunotherapy Bacillus Calmette-Guérin (BCG), which most people know as the tuberculosis vaccine.
The two options have never been compared, however, so doctors are frequently unable to recommend one treatment over the other.
A pioneering Phase 3 trial will assess the safety and effectiveness of the approaches with an eye toward helping patients choose the best treatment for their cancer. The BRAVO study (ISRCTN12509361), funded by the Yorkshire Cancer Research, will be led by Jim Catto, a professor of Urology at the University of Sheffield.
“Bladder cancer is a huge problem in Yorkshire. This vital clinical trial will help to identify the risk and benefits of each treatment,” Catto said in a news release. “Knowledge of these will allow better, more focused treatment of this disease, which should improve survival and quality of life outcomes.”
Patients who have a radical cystectomy to remove their bladder must also have a urostomy to let their urine drain to a bag outside their body. The surgery is not only invasive, but obviously has life-changing consequences.
Although BCG treatment can take up to three hours, it can be done on an outpatient basis. Although it is effective in some patients, nearly a quarter fail to respond to it and need to have their bladder removed anyway. The delay between the different treatments can affect patients’ chance of survival.
Since no trials have compared the pluses and minuses of the procedures to help patients decide which is best for them, those with bladder cancer not only have to deal with the diagnosis, but also with making a major, life-changing decision.
“This work will also build networks between bladder cancer surgeons in Yorkshire, to allow sharing of good practice and to improve the patient experience. The results of this study will be essential in helping us understand whether we will be able to undertake a larger, national trial,” Catto said.
The trial is in the process of enrolling patients from hospitals across Yorkshire, England. Those running the trial are seeking patients with a bladder cancer that is aggressive, but not invasive. Patients will be randomized to receive either surgery or the immunotherapy.
For more information on the trial, contact the BRAVO team at firstname.lastname@example.org.