Are you looking for a new bladder cancer treatment? Or would you like to help advance scientific and medical research so that others with bladder cancer have better treatment options? Joining a clinical trial might be an option for you. Clinical trials are large studies that recruit participants to learn more about how safe and effective new treatments are.

This article will discuss how bladder cancer clinical trials work and what you should consider before joining. These studies may offer new treatment options to those who need them. However, it’s important to weigh the risks and benefits. Be sure to talk with your cancer care team about clinical trials and how you can join one.

Understanding Clinical Trials

Clinical trials are large research studies that investigate new and better ways to treat cancer. These studies recruit human participants to try different treatments, including:

• New medications
• New procedures, like surgeries or ways to diagnose diseases
• New medical devices

Some clinical trials for cancer test new drugs, while others look at new ways of using existing drugs for different conditions.

According to the National Cancer Institute (NCI), clinical trials also help find new ways to improve your quality of life with cancer. Besides testing new treatments, researchers also test new ways to address side effects.

Types of Clinical Trials

When you think of a clinical trial, you might think of trying an experimental drug. However, these studies can include much more than new medications. Some clinical trials for cancer test new drugs, while others look at new ways of using existing drugs for different conditions.

Prevention trials are one form of clinical trial. They focus on preventing cancer. People who participate in these studies may not have cancer. If you’re at high risk of bladder cancer but haven’t been diagnosed, you might be eligible to participate in a prevention trial.

Some cancers have recommended screening tests to catch tumors early. Right now, there aren’t any standard screening tests for bladder cancer. Doctors and researchers are still collecting information to make a safe and accurate screening test. Clinical trials may soon study new ways to detect bladder cancer early.

Phases of Clinical Trials

Before the U.S. Food and Drug Administration (FDA) approves new drugs, they go through clinical trials. There are four main phases of clinical trials. You might see them written with Roman numerals — like phase II (2). Each phase is designed to learn different kinds of information about a new treatment.

Phases 1, 2, and 3 tell researchers how safe and effective a new treatment is. Phase 3 is the longest and largest phase. Participants receive the standard of care (the current standard treatment) or the new treatment so that researchers can compare the results. For example, there’s one active clinical trial in phase 3 that’s studying non-muscle-invasive bladder cancer. The researchers are comparing the standard of care — a type of immunotherapy called bacillus Calmette-Guerin (BCG) that’s administered intravesically (directly to your bladder) — with a combination of the chemotherapy drugs gemcitabine and docetaxel.

The clinical trial wants to find out whether chemotherapy is as effective or better than intravesical BCG for patients with non-muscle-invasive bladder cancer. The researchers randomize which participants get which therapy. In some studies, the doctors and participants are “double-blinded,” which means that they don’t know if participants are receiving the standard treatment or the new drug. When only the participants are blinded, but the doctors know which participants are getting which treatment, it’s called a “single-blind.” Blinding and randomization in clinical trials help prevent bias so that other factors unrelated to the treatments don’t affect the results.

If the chemotherapy treatment works well, the FDA may approve it for certain bladder cancers, and the treatment will move to phase 4. Phase 4 clinical trials monitor the long-term safety of new treatments.

Receiving a Placebo vs the Standard of Care

The NCI explains that researchers rarely use placebos in cancer clinical trials. Placebos are substances that don’t contain medication, like sugar pills, that are often used in studies. But instead of using placebos, cancer studies often use the approved standard of care to compare to new drugs. If you join a clinical trial that uses a placebo, you’ll be told ahead of time.

Cancer clinical trials often use the current approved standard of care, instead of a placebo, to compare to experimental drugs.

Although you may want to receive the experimental treatment over the standard of care in a clinical trial, there’s no guarantee you’ll receive the experimental drug. Blinding and randomization prevent you from knowing what you received until the study ends. It’s just as important for researchers to test the standard of care as it is for them to test the experimental treatment. The process helps measure whether a new treatment works as well or better than what’s already approved.

How Do You Know if You’re Eligible?

Before you can join a clinical trial, you need to make sure you’re eligible. Researchers lay out certain criteria you must meet. Most studies have inclusion and exclusion criteria. Inclusion criteria are requirements you must meet to join the study, while exclusion criteria prevent you from joining.

Some cancer clinical trials require participants to be a certain age and have a specific cancer type. Studies specifically for bladder cancer require you to:

• Be diagnosed with a specific type of bladder cancer, such as muscle-invasive bladder cancer
• Have a certain grade of bladder cancer, like high- or low-grade tumors
• Be healthy enough to undergo cancer treatment
• Meet specific criteria about past cancer treatments you have or haven’t received
• Have gene changes or mutations (biomarkers) in your cancer cells

Every clinical trial has a different set of eligibility criteria. These requirements aren’t personal. They’re specifically chosen to make sure everyone who joins can do so safely and to make sure researchers can answer their questions.

It’s important to talk to your cancer care team when you’re considering joining a study. Your oncologist (cancer specialist) can give you guidance on which trials are best for you. They’ll also discuss the risks and benefits of joining a clinical trial so you have all the information you need before enrolling.

Informed Consent and Participant Rights

If you’re eligible to join a study, the next step is to officially sign up. A member of the clinical trial team will walk you through the informed consent process. Informed consent ensures you know as much information about the study as possible before you join. You’ll use this information to decide whether you want to participate.

It’s important to talk to your cancer care team when you’re considering joining a study. Your oncologist can give you guidance on which trials are best for you.

During the informed consent process, the research team will explain:

• The purpose of the clinical trial
• The procedures, tests, and treatments you can expect
• The side effects you may experience
• The possible risks and benefits of participating

Be sure to ask the research team any questions you have. They’ll provide written documents you can read and discuss with your doctor, family, and anyone else who might help you make your decision. If you’d like to join the study, you’ll sign and return the informed consent papers.

Participants who join clinical trials have certain rights. For example, you can leave a trial at any time. Leaving a study doesn’t affect your access to standard medical care. You’ll still get treatment from your care team. You also have the right to learn updated information about the clinical trial as it runs.

How To Join a Clinical Trial

If you want to help advance bladder cancer research, a clinical trial may be right for you. Talk to your oncologist to see if they know of any potential studies you qualify for. You can also search online for ongoing bladder cancer clinical trials. Many researchers provide their eligibility criteria and study locations.

Some clinical trials currently underway are studying:

• Immunotherapy, like pembrolizumab (Keytruda) and nivolumab (Opdivo)
• Chemotherapy, like cisplatin and gemcitabine
• New approaches for metastatic bladder cancer that has spread throughout the body
• New ways to find out who may respond better to certain bladder cancer treatments

Talk With Others Who Understand

MyBladderCancerTeam is the social network for people with bladder cancer and their loved ones. On MyBladderCancerTeam, members come together to ask questions, give advice, and share their stories with others who understand life with bladder cancer.

Have you participated in a clinical trial for bladder cancer? What was your experience like? Share your story in the comments below, or start a conversation by posting on your Activities page.