A clinical trial could mean a big change in the type of care you're getting now. You may get a cutting-edge treatment that few people have had before.
Before you join, learn about how it works and what it will be like for you.
What Is a Clinical Trial?
It's a study that gives researchers a chance to show that a treatment works and is safe. The FDA won't approve a new drug, procedure, or medical device until it's gone through a clinical trial.
Sometimes clinical trials test drugs and procedures that are already approved by the FDA for other conditions. Researchers want to see if they might work for prostate cancer, too.
Trials also check to see if there's a benefit to taking two treatments together that are usually done alone.
How Does It Work?
There are several types of clinical trials.
There can be trials where patients get the typical medication used to treat cancer and a placebo or the experimental drug. In others, patients get the typical medication used to treat cancer or the experimental drug. There are also trials where patients can get a placebo or the experimental therapy.
Randomized trials. As the name suggests, you're assigned at random to an "experimental" or a "control" group.
If you're in the experimental group, you'll get your regular care and the treatment that the researchers are testing. If you're assigned to the control group, you'll get your regular care and a "placebo," which is sometimes also called a "dummy pill." It doesn't have any ingredients that can treat the disease. Researchers want to see how well the experimental treatment works when compared to the placebo.
Cross-over studies. In these, researchers start out by giving regular care and the experimental treatment to one group while people in the other group get their regular care and a placebo. Then the groups switch. Everyone eventually gets the experimental treatment.
Double-blinded studies. If you're in one of these kinds of trials, you'll get assigned to either an experimental group or a control group. But while the trial is going on, neither you nor the doctor will know which group is getting the experimental treatment and which is getting the placebo.
Your Care During a Clinical Trial
Doctors check the health of people in clinical trials closely, because they want to see how the treatment is working.
"Whether we are using a new drug or an established drug in a different clinical stage, we want to make sure that we aren't missing any important signals, good or bad," says Dana Rathkopf, MD, who runs prostate cancer clinical trials at Memorial Sloan Kettering Cancer Center.
This means you'll get a lot of attention and care. But it could mean many trips to the research center.
"For a new drug not used in many people ... the visits can range from daily to weekly to monthly," Rathkopf says. "For more-established drugs, when we already have a greater sense of safety, the visits may be spread out less frequently."
If your doctor isn't running the study, you may be able to continue to get your regular treatment from him. A lot depends on how the study is designed. If you continue to see doctors outside the study, research doctors will coordinate care with them.
"We work closely with their local physicians when patients want us to, and when they request that we manage more of their care in one site to save them multiple trips to multiple doctors, we do that, as well," Rathkopf says.
The Cost of a Clinical Trial
Usually the sponsors of a trial pay for the experimental drugs and everything that's related to it, such as tests and lab work. The bills for your regular treatment are sent to your insurance company.
Insurance companies can't drop you for enrolling in an approved study.
Your Safety During a Clinical Trial
Before researchers begin a clinical trial, a board reviews the plans to make sure they are safe. Before you join, a member of the research team will go over these points with you:
- What the experimental treatment is
- Known and possible risks
- Whether you might be getting a placebo
- Any treatments you might consider instead of experimental treatment
- Everything you need to do during the study, such as take medications, get tests and procedures, and see doctors
- Any money you'll have to pay
You get the chance to ask all your questions before you agree to take part.
How Do I Find a Prostate Cancer Clinical Trial?
Your doctor may suggest a specific clinical trial to you as one of your treatment options. If not, ask if he knows about one that would be right for you. He may also help you search for one.
Check these groups to find out about where to join a trial:
- National Cancer Institute
- The U.S. National Institutes of Health
- World Health Organization
- Prostate Cancer Clinical Trials Consortium
- Online clinical trial listing services, such as eCancerTrials, CenterWatch, and ClinicalTrialsSearch
The National Cancer Institute offers an online checklist of the information you need to search for a trial. Your doctor can help you fill it out. Once you find a trial that looks right for you, you or your doctor can contact the research team so you can apply.