What Bladder Cancer Patients Should Know About Clinical Trials

January 31, 2020

BCAN recently interviewed Dr. John Gore of the University of Washington Medicine. We asked him about the importance clinical trials and research, as well as patient participation in trials.

What got you interested in research and clinical trials?

Dr. Gore: At the beginning of my career, I had the opportunity to work with Dr. Mark Litwin who is now the Chair of Urology at UCLA. That year that I worked with Mark was very important to my thinking about how I wanted to approach my career. I learned that I wanted research to be part of my career. What research demonstrates effectively is how the gaps in care that we witness every day in our clinical practices have the potential to be solved. We have traditionally thought about those gaps as the treatments we need to enable patients have better health outcomes. The year that I spent working with Mark opened my eyes to all of the other gaps in care that we don’t necessarily see in our clinical practices. Gaps like access to care, quality of care, and quality of life, which is still an understudied issue.

It opened my eyes to how we can help patients be healthier in general, and not just in terms of their chief complaint. The means things like working with bladder cancer patients who are smokers and finding the teachable moments to talk with them about smoking cessation. What is cool about a research career is that it becomes part of your clinical practice, and your clinical practice becomes part of your research career.

Can you tell us a little bit about CISTO and the Patient Survey Network? How did the project evolve?

Dr. Gore: CISTO stands for a Comparison of Intravesical Treatment and Surgery, the comparison being bladder removal surgery as a treatment option for recurrent bladder cancer.. If you’re going to do a clinical trial, it makes a lot of sense to talk to patients before you come up with the plan for the trial. CISTO is a tremendous illustration of the power of patients to help us do better research. For CISTO, the origins began with BCAN’s Patient Survey Network, a group of patients who have agreed to answer survey and research questions a few times a year. We first started by asking our patient centered outcomes and policy working group to come up with some starter questions that patients could rank.

We also allowed patients to submit their own questions. It is amazing to see some of the questions that came out of patient input rise to the top of prioritized research questions.

Not surprisingly, the most commonly ranked question was about what to do when BCG stops working. That’s a huge conundrum for patients but it’s also a huge gap in knowledge and gap in care for clinicians. There are many examples of bladder cancer clinical trials where a lot of money was put into comparing two different treatment options, but the trial ended up failing because one of the treatment options was simply observational. This means that patients would randomly be assigned to one of two groups: a treatment arm or observation arm. The observation arm means that participants would be randomly selected to not get treatment.

Patients of course struggle to submit to the randomization for such an important and drastic difference between the two treatment choices. For bladder cancer patients, this may mean that participants could get a radical cystectomy or they may not. Patients don’t like leaving things like that up to chance. Only 10% of patients would be willing to submit to the flip of a coin to be randomized to that treatment comparison. It’s very clear that if we tried to do a randomized clinical trial that it would be subject to some of the same recruitment failures that other trials have been subject to.

At the end of CISTO, based upon the way that we’ve designed it, we will be able to better understand which patients are best for more aggressive treatment with bladder removal. We will have a better sense of which patients can have good outcomes with salvage treatments into the bladder, and what are the factors for right patient getting the right treatment at the right time.

What do you want patients to know about research and clinical trials?

Dr. Gore: I would want them to know that clinical trials are really important part of discovery. One of the hardest things for patients to consider as they think about a clinical trial is, is there any chance that this clinical trial is going to harm them? What I would encourage patients to understand is that in these clinical trials, we’re trying to compare known, established treatments with experimental treatments. We’re never excluding a patient from care or restricting him or her from care. We are just trying to figure out how to make care better. The involvement of patients in that research process it’s so critical. We are so grateful for every single patient that signs up for a clinical trial because they are directly helping us make care better. So that’s what I would emphasize, that we are tremendously grateful to patients for even considering participating in a clinical trial.