Perhaps you’ve had hormone therapy for prostate cancer, but your prostate-specific antigen (PSA) level is rapidly rising. What are your options? If you have a prostate condition and find yourself in a situation where your current treatment choices are unsatisfactory, you may want to enroll in a clinical trial.
A clinical trial evaluates how well new medical, surgical, or complementary treatments are safe and effective in people. These studies test new methods of screening, preventing, diagnosing, or treating a disease, or they compare innovative treatment approaches with the standard treatments. Most of the medical advances in recent decades were first evaluated in a clinical trial—and millions of Americans have taken part in these important research studies.
Clinical trial phases
Clinical trials are conducted in four phases.
Phase I. Investigators test an experimental treatment or procedure in approximately 20 to 80 healthy volunteers to evaluate safety, identify side effects, and determine a safe dosage range.
Phase II. Researchers study the effectiveness of the new treatment or procedure and further evaluate safety in 300 or more people who have the disease. Trials typically last several months.
Phase III. These trials compare an experimental treatment, a new drug combination, or a new procedure with the best existing treatment in several hundred to several thousand people with the condition. They are designed to confirm effectiveness, monitor side effects, and collect additional safety information. Trials often last several years.
Phase IV. These trials involve several hundred to thousands of people and are carried out to evaluate long-term effects of a treatment or procedure after its approval by the Food and Drug Administration.
Know the terminology
When considering clinical trials, you’ll likely confront these terms:
• Randomization. In a randomized trial, you will be assigned by chance to either a treatment group, a control group, or a placebo group. If you’re assigned to the control group, you will receive the standard treatment or procedure that you would receive if you were not participating in the study. If you are assigned to the treatment group, you will get the experimental treatment or procedure. If you are assigned to the placebo group, you will receive an inactive pill or sham treatment that has no effect on the disease.
Today, placebos are never used when a patient could benefit from a known, effective treatment; thus, many studies, including most cancer trials, do not have a placebo group. However, a placebo group may be used if there is no standard therapy with which to compare the experimental treatment.
• Blinding. Some randomized studies are blinded, which means you won’t know whether you’re getting the investigational or standard treatment until after the trial is over. In a double-blinded study, neither you nor the investigators will know which treatment you are getting until the end. Blinding minimizes the chances that a treatment seems to work only because of the expectations or biases of those involved in the study.
Participating in a clinical trial can have advantages and disadvantages, so ask questions at every step of the process. Your urologist or oncologist is the best place to start. He or she will be familiar with any large trials you might benefit from participating in. Information about clinical trials enrolling patients is available below.
Keep asking questions
As you begin serious consideration of a particular trial, speak with the study coordinator about the purpose and scope of the study, the treatment’s potential risks and benefits, the types of medical tests and procedures required, qualifications of the researchers and staff, the length of the trial, and which patient expenses are not covered.
If you decide to enroll, you’ll be asked to sign a consent form. The study coordinator will explain each section to you, and if you don’t understand something, ask questions until you’re satisfied that you know exactly what will be required of you, and what you can expect.
Feel free to take the consent form home so that you can review it with your doctor and family before signing. Seriously consider the commitment you’re about to make. Although you can withdraw from a trial at any time for any reason, a high number of withdrawals may affect the integrity of the study and weaken its results. You are signing an agreement based on trust between you and the researchers, with both parties agreeing to meet their responsibilities to the best of their abilities.
Find a clinical trial
Clinical trials are sponsored by government agencies, medical institutions, pharmaceutical companies, foundations, and other organizations.
To look for a trial, go to Clinicaltrials.gov and type in the name of the prostate condition you’re interested in. Clinicaltrials.gov is a searchable database maintained by the National Institutes of Health. Don’t forget to check the eligibility criteria: You must meet those requirements in order to participate in the trial.