Prostate Cancer

Understanding clinical trials

Clinical trials are studies that evaluate whether new treatments are safe and effective in humans. In addition to validating a new drug or procedure’s safety and effectiveness, clinical trials help doctors determine the treatment’s side effects and best dosage. The results of clinical trials help the U.S. Food and Drug Administration (FDA) decide whether to approve the new treatment, which makes it available for public use. Without patient participation in clinical trials, the prostate cancer treatments we have today would not be available.

Benefits of participating in a clinical trial

Participating in a clinical trial offers many benefits, including early access to potentially effective new treatments and receiving the best standard of care and close monitoring by experts. Clinical trial participants also play an important role in the scientific process and can help other people with cancer. A clinical trial may help you, and your participation in one will definitely help doctors and future patients. Clinical trial participants are always volunteers and can leave the trial at any time for any reason.

Many people associate clinical trials with the use of a placebo. A placebo is an inactive pill or fake treatment used in some types of clinical trials. Some people may be nervous about participating in a clinical trial because they believe they could receive a placebo instead of real treatment. This is not true. Placebos are rarely used alone in cancer research, and they are never used instead of an effective treatment. People in cancer clinical trials will always receive the standard of care. Do not let the myth that you will receive a placebo instead of treatment dissuade you from participating in a clinical trial that could help you.

Glossary Terms - Words to know

Blind study: A study in which the participants do not know which treatment group they are in. In a single-blind trial, the patients do not know which treatment they’re receiving, but the doctors do. In a double-blind trial, neither the patients nor the researchers know who is receiving the experimental drug.

Control group: The group of participants assigned to receive the standard of treatment being compared with an experimental treatment.

Eligibility criteria: The qualities a patient must have to participate in a given trial (age, sex, cancer type, etc). Institutional review board (IRB): A group of people responsible for protecting the rights and welfare of study participants and ensuring that the study complies with federal law.

Principal investigator (PI): May also be called the clinical investigator. The person in charge of the study.

Protocol: The set of rules that all institutions participating in a given clinical trial must follow. The protocol outlines the eligibility criteria, specifies which tests and procedures will be used and performed, describes medications that will be administered and establishes the length of the study.

Standard treatment (or therapy): The drug or treatment that experts agree is the appropriate therapy for a particular type and stage of cancer.

Safety in clinical trials

Clinical trials are safe for participants. All clinical trials must go through the same process to get the FDA’s approval. Strict scientific and ethical guidelines must be met and followed while each clinical trial is being developed and monitored. These studies are conducted under the direct supervision of physicians and expert research professionals, and every participating clinic, hospital, university or cancer center must follow the same set of rules, called a protocol.

The protocol outlines the eligibility criteria, specifies the tests that will be used and procedures that will be performed, describes the medications and their doses, and establishes the length of each study. Several safeguards are in place and regulated to guarantee the safety of all participants in a clinical trial. Before researchers can study a treatment in humans, the treatment has to go through preclinical testing (laboratory or animal studies) to establish whether it is safe for humans and could work as intended. Preclinical testing can take several years to complete. At this point, the pharmaceutical research company must file an Investigational New Drug Application (IND) with the FDA. The IND must include results from the preclinical studies, protocols for all proposed clinical trials, and the drug’s ingredients, manufacturing and processing information. This gives the FDA a chance to review the study before participants are involved. A trial can enroll volunteers only after the FDA approves it.

Once a trial starts, it has many built-in safeguards that protect participants as the trial continues, such as an institutional review board (IRB). An IRB is a group of people responsible for protecting the rights and welfare of study participants and ensuring that the study complies with federal law.

How trials work

Each clinical trial establishes a set of characteristics its participants must have. This set is called eligibility criteria. Cancer type and treatment history are two common examples of eligibility criteria. The clinical trial staff will be able to determine whether you are eligible to participate in a specific trial.

Clinical trials are generally conducted in three distinct phases that build on each other. If you enroll in a clinical trial, it will most likely be one of these phases. Phase I trials are usually the first time the treatment is evaluated in humans. The goal of phase I trials is usually to determine the dose that works best without causing severe side effects. In a phase II trial, doctors learn more about the treatment’s safety and how well it works for a specific cancer. If the new treatment is likely to work and is as safe as the standard treatment, research moves to a phase III trial. A phase III trial enrolls more volunteers to compare the new treatment with the standard of care. With more volunteers, researchers have more data and can evaluate whether the new treatment really is better than the standard of care. The goal of a phase III trial is to find out whether the new treatment is better than the standard treatment and/or has fewer side effects than the standard treatment.

Finding a trial

Your location doesn't limit your participation because clinical trials now take place at local hospitals and cancer centers as well as at major medical centers. You may find one in your town, or you may have to travel. If you are interested in participating in a clinical trial, you have a few methods of finding one that’s right for you. Ask your medical team if they can recommend a clinical trial for you. Current clinical trials with open recruitment can be found at Trials labeled “open” are recruiting new volunteers, and trials labeled “closed” are not recruiting new volunteers. In addition, a number of government and private organizations provide listings of clinical trials and information about trials on their websites (see below).

Find a clinical trial

You can search for prostate cancer clinical trials at the following sites:

Clinical Trials Myth vs Fact

MYTH: Clinical trials are only for people who have no other options for treatment (a “last resort”).

FACT: Cancer clinical trials are designed for people with cancer of all types and stages.

MYTH: Signing a consent form to participate “locks” you into staying in a trial.

FACT: After you sign a consent form, you can still change your mind and not participate in the trial. You can decide to leave the trial at any time for any reason.

MYTH: Some participants in a clinical trial get a placebo (sugar pill) instead of treatment.

FACT: Participants in cancer clinical trials will receive the standard of care as a foundation and then the experimental treatment or a placebo will be added to it. Although rarely the case today, if a placebo is used, study sponsors are required to disclose this information to patients ahead of time so that patients can make an informed decision about participating.

MYTH: Clinical trials are not safe.

FACT: Clinical trials have many built-in safeguards to protect participants’ rights and safety, such as an institutional review board, data and safety monitoring board and an ongoing informed consent process.

MYTH: Clinical trials only take place at large hospitals or cancer centers.

FACT: Many clinical trials take place at local hospitals, cancer centers and doctors’ offices. Clinical trials occur in all parts of the country, in both rural and urban areas.

MYTH: A clinical trial must be recommended by a doctor in order for a person to participate.

FACT: If your doctor does not talk to you about clinical trials, raise the topic yourself. You can also search for clinical trials online; contact information for each trial is provided.

MYTH: The cost of care in a clinical trial is not covered by health insurance.

FACT: Under the new health care laws, patient-care costs (such as going to the doctor, hospital stays or certain testing procedures) may be covered by insurance. It's common, but not guaranteed, for the trial sponsor to cover research costs directly related to the study, and insurance does not typically cover research costs. Any questions about coverage should be provided before entering into a clinical trial.