Clinical Trials for Invasive and Metastatic Bladder Cancer

What Are Bladder Cancer Clinical Trials Studying Now?

Researchers are now studying how some people with muscle invasive bladder cancer can keep their bladder safely.

This is a growing area of research. But muscle invasive bladder cancer is an aggressive disease. When cancer hasn't spread beyond the bladder, surgery can still offer a chance for a cure.

So if you decide to keep your bladder, your doctor will need to watch you carefully to make sure the cancer doesn't come back.

Can Blood or Urine Tests Help Guide Treatment?

Another area of research looks at tests that search for tiny traces of cancer DNA in the blood or urine:

• Blood tests may look for circulating tumor DNA (ctDNA)
• Urine tests look for bits of tumor DNA that end up in your pee (uDNA)

Chatzkel says tests like ctDNA aren't perfect. If your test doesn't show any ctDNA or uDNA, it doesn't guarantee the cancer is gone. These tests also don't replace your:

• Biopsy
• Bladder exam
• Imaging scans
• Regular follow-up visits

But sometimes, not finding traces of cancer DNA after treatment can be "an encouraging sign," says Chatzkel. Blood and urine tests for cancer are still being studied and fine-tuned.

The long-term hope is that they'll help doctors better match treatment to each person's actual risk. That way, you'll get personalized treatment just for you, instead of treating everyone with bladder cancer the same way.

What Comes After Standard Treatment for Metastatic Bladder Cancer?

Chatzkel describes about the thinking behind many trials this way: "Maybe enfortumab isn't working anymore. What do we want to do next?" That question has led to several areas of research such as new immunotherapy and targeted treatments.

Immunotherapy

Clinical trials are studying how to use immunotherapy in new ways, including before or after bladder surgery. Some studies are testing newer immune-based treatments, such as bispecific antibodies.

These drugs can attach to more than one target at the same time. This may help bring immune cells close to cancer cells and boost the immune attack.

Targeted therapies 

Targeted therapies are drugs designed to go after specific changes or markers in cancer cells. One important target in bladder cancer is the FGFR3 protein that helps the cancer grow.

If your tumor has makes too much, you may be able to join a trial testing an FGFR inhibitor. Tumor testing is an important part of metastatic bladder cancer care. It can help your doctor find approved treatments or clinical trials that fit your cancer.

Antibody-drug conjugates (ADCs)

Traditional chemotherapy for bladder cancer, like cisplatin, travels through your whole body to kill any fast-dividing cells, not just cancer.

The goal is to deliver a stronger treatment more directly to cancer cells. This doesn't mean ADCs have no side effects. The same target may also be found on some healthy cells, and the drug can still affect other parts of your body.

For metastatic bladder cancer, this may be one of the most important areas of research to ask about if your current treatment is no longer working.

How Do You Know if a Clinical Trial Is Right for You?

Whether or not a trial is a good fit also depends on things like:

• Your cancer stage
• Treatments you've already tried
• Your overall health and other conditions
• Whether your tumor has certain gene changes 

Other things to think about before starting a trial

Some parts of the decision may have nothing to do with your cancer. If a study means long travel or a lot of extra visits for a treatment that may only be slightly better, "that's a big ask," says Meeks.

But not every trial adds a huge burden. Chatzkel says the extra steps can vary a lot from study to study. Some trials may not require much more than coming in for treatment the way you would normally.

Other trials, especially earlier-phase trials, may involve more visits, tests, and follow-up. Before you decide, ask the clinical trial team to:

• Go over all the details.
• Give you the consent form to take home.
• Allow you the time to review the consent form.

Remember, you don't have to decide on the spot.

Will You Get a Placebo?

Chatzkel says a lot of people ask questions like: "Am I going to get no treatment? Am I going to get something that's inferior?"

Most of the time, he says, one group gets the new treatment and another group gets the standard of care. The standard of care is a proven treatment that's already approved for use.

When is a placebo used?

If a study does include a placebo, you'll be told that upfront and your team should walk you through exactly what that means.

Chatzkel also stresses that these studies go through careful review. Before a clinical trial can start, a group called an institutional review board (IRB) looks at the study design. Their job is to make sure the trial is ethical and protects your rights, safety, and well-being.

But if you take part in a bladder cancer study, expect some uncertainty.

"We have a particular trial because we think it's promising, but we don't know whether the treatment is going to benefit you, in particular," Chatzkel says. "If we knew that, we wouldn't be doing the trial. We would just be giving the treatment to patients already."

What Are the Pros and Cons of Clinical Trials?

Clinical trials are one way doctors learn whether new treatments are truly better than standard care. For some people, that can come with real advantages.

Chatzkel notes that this is why informed consent is so important. Before you join, ask questions and make sure you understand:

• What question the study is trying to answer
• What treatment(s) you might get and if there's randomization
• What visits and tests you need and how often
• Possible risks and side effects to watch for
• Other treatment options you'd have if you don't join the trial
• Your rights, including how to leave the study if you change your mind

A good team will help you weigh these pros and cons so you can decide whether a trial feels like the right choice for you.

How to Find a Bladder Cancer Clinical Trial

Start by asking your cancer care team if there are any clinical trials that fit your type and stage of bladder cancer. Even if they don't run trials themselves, your doctor may know what's available nearby or at larger centers.

It's reasonable to get a second opinion from a bladder cancer specialist at a major cancer center, especially if your doctor doesn't see a lot of people with muscle invasive or metastatic bladder cancer. Or if you're not sure about your options, asking for another opinion can help.

Sometimes, a single visit with a specialist, even by telehealth, can help you find out what trials might fit you best. You might also learn more about approved treatments that you haven't tried yet.