What it's like to participate in a clinical trial for bladder cancer

Ssometimes numbers tell a story, but sometimes they hide it. According to the latest data from the National Cancer Institute, the death rate for people diagnosed with bladder cancer has barely changed over the past 30 years. But experts who treat the disease tell a different and more hopeful tale — and they attribute much of it to the surge in clinical trials. “Just in the last five or six years, there’s been a lot of work looking for new therapies for bladder cancer patientsand we’re seeing unprecedented reactions with some of these new drugs,” says Stephen A. Bourjian, MD, professor and chairman of the division of urology at the Mayo Clinic in Rochester, Minnesota.

Some of the biggest advances in the treatment of bladder cancer involve a class of drugs called immune checkpoint inhibitors. They change the activity of a person’s immune system in ways that help it fight cancer cells. “They changed the paradigm,” Bourjian says. “The way we treat bladder cancer is different than it was just five years ago.”

Others in his field tell a similar story. For people with both metastatic and non-metastatic bladder cancer, the past half decade has seen the introduction of dozens of promising new treatments. Some have been revolutionary, while others have led to incremental but important improvements in care. In any case, this progress depends on the clinical trials and the people who participate in them.

“Clinical trials are how we got here,” says Dr. Guru Sonpavde, director of the bladder cancer program at the Dana-Farber Cancer Institute and associate professor of medicine at Harvard Medical School in Boston. “All of the new drugs that we have that have changed outcomes for patients with bladder cancer — they all come from clinical trials.”

Clinical trials are carefully designed research studies conducted in a medical setting that help experts identify new or better ways to prevent, diagnose, or treat disease. “Participating in a trial is often the only way to gain access to new and promising drugs or to therapeutic alternatives that may be better than standard care,” explains Sonpavde.

Although almost every type of cancer is the subject of ongoing research, he says bladder cancer may be one of the hottest areas for work in clinical trials. Part of this is due to the spread of cancer; Bladder cancer is the sixth most common cancer in the United States, with more than 80,000 new cases diagnosed annually. But another factor is that, until recently, decades had passed without major breakthroughs in bladder cancer treatment. “We had some chemotherapies, but this was a cancer where we hadn’t seen much progress until about five years ago,” Sonpavde says.

Like Boorjian, he highlights the game-changing effect that immune checkpoint inhibitors are having on bladder cancer treatment. This and other advances have led to an explosion in new research—and with it, a need for more people to participate in clinical trials.

Unfortunately, this need is not met. “There are so many drugs and therapies being investigated in this space that in some cases there hasn’t been enough patient participation to validate study results,” said Dr. Ashish Kamat, Endowed Professor of Urologic Oncology and director of the study. of bladder cancer at MD Anderson Cancer Center in Houston. “To get reliable results, trials need a lot of patients, and until we have more participation, it will be difficult to move the needle as much as we would like.”

How to find clinical trials

Part of the problem, Kamat says, is that many people with bladder cancer may not know they are eligible to participate in a clinical trial. Cancer doctors—especially those not affiliated with major research institutions—often fail to present these options to their patients. “I’ve given educational talks to patient groups and people have come up to me and said they had no idea this option existed,” he says. “In some cases, they end up coming to Houston and participating.”

He recommends that patients initiate the topic themselves; simply asking your doctor if clinical trials are worth exploring may be enough to get you started. Also, websites such as ClinicalTrials.gov, which is maintained by the US National Library of Medicine, provide up-to-date information on ongoing research trials. You can easily search for clinical trials that are actively recruiting participants in your state or city. Meanwhile, most major health systems and research institutions maintain their own patient sites that include clinical trial information. For example, MD Anderson, Dana-Farber, and the Mayo Clinic provide these online resources.

Not everyone with bladder cancer will be a good candidate for a clinical trial. For some, the current standard of care may provide the most effective treatment for the disease. “For a patient who has low-grade bladder cancer, resection” — that is, surgical removal of the tumor — “has a very high cure rate,” says Kamat. “It may not be advisable for this patient to participate [in a trial] because the standard of care is so effective.

On the other hand, the prognosis for those with metastatic bladder cancer—ie. cancer that has spread to other parts of the body – may make the prospect of a trial more attractive. “Unfortunately for patients in this space, existing therapies do not provide sustained long-term survival,” he says. Clinical trials may provide their best opportunity to beat the average. They can also provide alternatives to invasive procedures. Kamath says that among those with non-muscle-invasive bladder cancer — a group that makes up about 75% to 80% of new bladder cancer patients — some don’t respond well to current drugs. These patients usually need to have their bladder surgically removed. “It’s an invasive, life-changing procedure, and clinical trials may provide another option,” he says. Of course, each case is different and should be evaluated by the patient’s physician.

Some may be hesitant to sign up for what is essentially an experiment. But clinical trials are strictly regulated to ensure that participants are not exposed to undue risks. Dana-Farber’s Sonpavde says clinical trials are always built on a foundation of previous work that suggests the intervention — that is, the new treatment or other thing being studied — is at least not too risky compared to the current standard of care. and that there is evidence that it may be beneficial. “Once a trial is done, you now have basic research showing that the intervention is promising,” he says. There is always some element of risk. But with that risk comes the potential reward of gaining access to new and better cancer care, he says.

Read more: The latest discoveries that may help bladder cancer patients

What it’s like to participate in a clinical trial

Let’s say you and your care team have identify a clinical trial this may be appropriate. You will then meet with someone associated with the trial who will make sure you understand exactly what the trial involves. You will receive a detailed explanation of the study design, as well as any potential risks or disadvantages.

If you decide you want to go ahead—that is, if you give your informed consent—you’ll likely go through some kind of screening process to make sure you meet the trial’s criteria. It may include additional tests – scans, biopsies, blood tests – as well as a review of your medical records. “Sometimes we start doing these assessments and something comes up that makes the patient ineligible,” Sonpavde says. For example, the genetic makeup of your cancer may end up not meeting the test’s guidelines, or you may be taking medications that would interfere with treatment. But if the screening goes well, you’ll likely start the test soon — usually within one to three weeks.

It is important to emphasize that in many clinical trials some people do not receive a new drug or new treatment. In other words, they are part of a “control” group that will help the research team assess whether the new intervention is providing benefit. “Overall, the trial will compare the new treatment with the standard treatment,” Sonpavde explains. In other words, even if you don’t get the new treatment, you’ll be no worse off overall than if you hadn’t signed up.

Another benefit of participating in clinical trials is that in some cases – whether you receive the new intervention or the control intervention – the cost of your treatment will be covered by the trial. Outside of a clinical trial setting, some cutting-edge drugs would cost thousands of dollars—or might not be available at all.

On the other hand, clinical trials will usually not cover accommodation or transportation costs for participants. This can be a major obstacle for those who do not live in cities or near research institutions. Additionally, participants typically receive no compensation.

Read more: Transforming cancer care so that patients no longer feel like numbers

What is happening now

Almost every aspect of bladder cancer is now the focus of clinical research. But a few areas are the subject of particularly strong interest.

Boorjian says new treatments for non-invasive bladder cancer are one of the most active areas of research. He recently led a study looking at something called adenoviral vector therapy. “This involves infusing the new drug into the bladder to stimulate the immune system to attack the bladder cancer,” he says. His trial found promising results, and his group is now recruiting participants for some related trials. Meanwhile, Boorjian says much ongoing research is looking for new and improved ways to deliver effective treatments. For example, some studies are investigating time-release mechanisms for drugs that may offer advantages over standard intravenous injections. “We’re looking for better ways to administer drugs to minimize the risk of toxicity,” he says.

Another hot area of ​​bladder cancer research focuses on personalized therapies for metastatic cancer. These precision drugs can be directed to specific targets identified on tumors. Boorjian mentions some new classes of therapies that are designed to target specific genetic mutations in a person’s cancer cells. “We’re starting to target therapies to these tumors, and that’s another change that’s moving the field forward,” he says.

Changing history

The National Cancer Institute estimates that more than 80,000 people will be newly diagnosed with bladder cancer this year alone. More than 17,000 people with bladder cancer currently will not live to see 2023. Improving these numbers will depend on clinical trials and the people who take part in them.

“The only way to make further progress is for patients to be involved in this work,” says Sonpavde. Again, not everyone will be suitable and taking part in a trial may involve some risk. But you have very little to lose—and a lot to gain—by ​​exploring your options with your care team.

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