Bladder cancer clinical trial to help patients faced with life-changing decision
A pioneering clinical trial led by scientists at the University of Sheffield will help bladder cancer patients who are faced with a life-changing decision during treatment.
Bladder cancer patients are often faced with a difficult choice – whether to have their bladder removed completely or to undergo a three year course of Bacillus Calmette-Guérin (BCG) treatment, which is a type of immunotherapy drug.
Until now, the two very different options have never been compared directly to understand which might be the best choice for individual patients, so doctors are frequently unable to provide guidance on whether to choose one or the other.
This means patients are forced not only to deal with a cancer diagnosis, but also to choose between major surgery that has high short-term risks and life-altering consequences, or a lengthy course of treatment that may have side-effects and could fail to stop the cancer progressing.
The issue was raised as one of the top five bladder cancer research priorities by the National Institute for Health and Care Excellence (NICE).
As a result, Yorkshire Cancer Research announced funding for the BRAVO trial, led by Professor Jim Catto, Professor of Urology at the University of Sheffield.
Incidence and mortality rates for bladder cancer in Yorkshire are higher than the national average. Incidence rates are particularly high in North Kirklees, Hull and East Riding Clinical Commissioning Groups, while mortality rates are highest in North Kirklees, Wakefield and South Tees Clinical Commissioning Groups.
Professor Catto said: "Bladder cancer is a huge problem in Yorkshire. This vital clinical trial will help to identify the risk and benefits of each treatment. Knowledge of these will allow better, more focused treatment of this disease, which should improve survival and quality of life outcomes.
"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."
The trial, which is currently recruiting patients from hospitals across Yorkshire, is the first step to see if it is possible to carry out a larger study to compare BCG treatment and bladder removal. Half the patients that take part in the trial will receive BCG therapy and half will undergo full bladder removal, called a radical cystectomy.
Gary Chappell, 71, is taking part in the trial and recently had his bladder and prostate gland removed after having his treatment chosen at random by a computer.
Gary, a former heavy goods driver who lives in the High Green area of Sheffield, was diagnosed with bladder cancer after experiencing a large amount of blood in his urine.
He said: "I'd noticed a tiny drop of blood months before, but I just didn't think it was anything to worry about. I've always been healthy. I don't smoke or drink and I've stayed quite active even after retiring.
"Last summer I went to the loo and loads of blood came out. It was really scary. I called for my wife and she got the emergency doctor out. They said to go to A&E if it got any worse, but I drank a lot of water and eventually my urine went back to normal.
"Even though the blood went away, I booked an appointment to see my own GP, who sent me to the urological clinic. I had two scans that showed I had four tumours inside my bladder. It was a huge surprise."
In August last year, Gary underwent an operation to remove the tumours. He was also given a chemotherapy drug directly into the bladder to try to kill any remaining cancer cells, and his tumours were sent for analysis.
During a follow-up scan, more tumours were found, and two weeks later he underwent another operation to have the growths removed. It was following this operation that he was given the choice between having a radical cystectomy and BCG treatment.
Patients who have their bladder removed also undergo a procedure called a urostomy, which means urine is drained via an artificial opening called a stoma, which is connected to a bag on the outside of the body.
BCG is a vaccine used to prevent tuberculosis, but it is also an effective treatment for some bladder cancers. It is usually given to patients via the outpatient department, and can take up to three hours.
Side effects can include pain when urinating and flu-like symptoms. A quarter of patients who undergo BCG treatment eventually need to have their bladder removed anyway and the delay can mean the chance of survival is lower.
Gary said: "I didn't fancy wearing a bag, but I also knew the treatment could have massive impact on my life. It would have meant going to the hospital a lot and it might have made me feel ill. I've always been active and I didn't like the thought of not being able to do what I've always done.
"I asked a lot of people, including surgeons and dentists, what they would do – some advised me not to have my bladder out, some said if it were them they would go through with the surgery. Everyone had different opinions. Taking part in the trial took the decision away from me. I decided I'd just go with the flow and see what the computer decided.
"I felt okay when I was told I would be having my bladder removed. It was what my family wanted. We all wanted it to be over and done with so we could move on. I hope that by being a part of Professor Catto's research I will help others going through the same experience."
After his recovery from surgery, Gary is now getting used to living life with a urostomy bag and is positive about his future.
He said: "I've recently been feeling really good. I expected the bags to be much bigger, so it was a nice surprise to find that they were small. The stoma nurse came round to see me and teach me how to use it and within a couple of days I'd got used to it. That part's been the easiest."
Patients are eligible for the trial if they have been recently diagnosed with aggressive, but not invasive, bladder cancer. For more information, please contact the BRAVO Team by emailing ctru-bravo@leeds.ac.uk.
