What to Know About Clinical Trials
- Clinical trials give researchers an opportunity to try out new treatments, such as combinations of immunotherapy and surgery, that might improve the outcome for people with bladder cancer.
- People with bladder cancer can enroll in a clinical trial at any stage or point in their treatment.
- To find a clinical study, start by asking the doctor who treats your cancer.
Enrolling in one of these studies can give you access to a breakthrough treatment before it’s FDA-approved. And if your diagnosis is a late-stage bladder cancer and current treatments haven’t stopped your disease, that experimental treatment might just prolong your life — or possibly cure your disease.
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“For patients who have stage 4 bladder cancer… I may direct them toward a clinical trial that involves immunotherapy if I feel that that is their best treatment option,” Dr. Arjun Balar, assistant professor of medicine and director of the Genitourinary Cancer Program at the NYU Perlmutter Cancer Center, tells SurvivorNet.
Doctors are using these studies to learn more about innovative ways to treat bladder cancer, such as by incorporating newer immunotherapies into other treatment regimens. “In patients who have stage 4 bladder cancer, we are now doing trials to assess if we can give immunotherapy after surgery to see if we can prevent stage 4 from happening in the first place,” Dr. Balar says.
What to Know Before You Enroll
Taking part in a clinical trial is a big decision, and one you shouldn’t enter into without a lot of careful thought and consideration. Before you make that decision, here are a few things to know about clinical trials for bladder cancer.
These studies are divided into phases, each of which has a different purpose.
- A phase I trial involves only a few people. Its goal is to find out whether the treatment is safe, not whether it works. This is the riskiest of the trial types, but the investigational therapy may help some people.
- A phase II trial includes about 25 to 100 people. It’s meant to see if the treatment is effective at shrinking or stopping the cancer, and if people who get the treatment live longer than those who don’t.
- A phase III trial includes several hundred people. Its purpose is to find out whether the treatment is more effective than the treatments that are currently available.
Some studies compare the new treatment against a placebo, which is an inactive pill or shot. You likely won’t know whether you’re getting the real treatment or a placebo until some time after the study ends. The possibility that you might not get any treatment, especially if your cancer is advanced, is important to consider. But if you’ve exhausted your other treatment options, it may be worth taking the risk.
How to Find a Clinical Trial
If you’re interested in joining a clinical trial, the place to start is with the doctor who treats your cancer. Ask if any studies are available at your cancer hospital, or close enough for you to travel.
You can also search the Clinicaltrials.gov website, which is the National Institutes of Health’s database of studies. The results will list the location of the study, the type of treatment it is evaluating, as well as the requirements you must meet to participate in the trial.
Questions to Ask
Once you do find a study that seems to fit, talk with someone involved in the trial. That could be the person in charge of the study (principal investigator) or a research coordinator. Here are a few questions to ask:
- What outcome is this trial studying?
- What do you know about this treatment?
- What phase is this clinical trial?
- What kinds of tests and treatments will I receive?
- Who will cover the costs of those tests and treatments?
- Will the study pay for my travel costs?
- What side effects might I have from this treatment?
- What are the odds that I will receive a placebo?
- If I do get a placebo, will I have a chance to get the study treatment later? If so, when?
- Who can I call if I have questions or problems?
It’s also a good idea to get a second opinion from your doctor, who can tell you whether the study is worth considering based on your unique medical history.
The Benefits of Enrolling
For some people with bladder cancer, clinical trials prove to be lifesaving. Others don’t have such great success.
But by taking part in a clinical trial, you’re not only helping yourself. You’re also helping researchers develop treatments that could improve the outcome for many other people with bladder cancer in the future. The treatment you take part in developing could one day become the new standard of care for bladder cancer.