The decision to enroll in a clinical trial should involve a discussion between the person with prostate cancer and that individual’s physician. Participation will depend on many factors, including the motivation for enrolling in a trial, the stage of the prostate cancer, and the trials available.
Different Types of Prostate Cancer Studies
There are many different reasons as to why researchers conduct prostate cancer clinical trials. These can include:
- Testing a therapy, such as a drug or other medical intervention, for treating existing prostate cancer. These are known as interventional trials.
- Finding ways to stop the development of prostate cancer, including changes in lifestyle, diet, or medications. These are called prevention trials.
- Evaluating ways to better diagnose prostate cancer. These are referred to as diagnostic and screening trials.
- Studying prostate cancer in a large group of people to better understand it as a health issue. This is known as an observational trial or a non-interventional study.
- Examining ways to improve the comfort and quality of life for people with prostate cancer. These are often called supportive care trials or quality of life trials.
In the case of new treatments (interventional trials), three separate trial phases are required by U.S. Food and Drug Administration (FDA). If the trial is taking place elsewhere, those phases are required by the equivalent governing bodies of the country where the trial is being conducted.
Some Current Areas of Prostate Cancer Interventional Studies
Interventional trials are the most common type of clinical trial involving people with prostate cancer. Medical researchers are now studying several new and promising approaches in prostate cancer treatment.
Chemotherapy studies involve examining new drugs and, in some cases, drug combinations to treat the existing cancer. Scientists are developing biological therapies that interrupt the molecular processes which cancer cells require to grow. Immune therapies involve boosting the body’s immune system so that it can better fight cancer. Tumor-directed treatments target the cancer cells themselves, and are aimed at killing cancer cells while minimally affecting other cells in the body. Stem cell therapy is another approach currently being used to treat prostate cancer, and being improved upon through research. This can involve allogeneic transplantation (from another person) or autologous transplantation (from one’s own blood-forming stem cells).
Phases of Interventional Trials
Interventional trials in prostate cancer, while the most common type of study undertaken by researchers, has different levels of investigation. If you or someone you know is involved in an interventional clinical trial, knowing the trial’s phase can tell you more about what is involved.
Phase 1 testing is the first type of study done in humans. Its purpose is to determine safety and to evaluate side effects. Phase 1 studies also test how the drug is absorbed, distributed, and eliminated from the body. Often people who do not have the disease (healthy individuals) participate in Phase 1 trials. The number of people involved at this stage is usually small.
Phase 2 trials are sometimes divided into Phase 2A and Phase 2B. Sometimes these two sub-phases are combined. Phase 2 trials further assess dosing, and are designed to determine the best drug dose to use and how much of a drug is safe. Phase 2 studies are done in small numbers of prostate cancer patients, and can also measure treatment efficacy. Often a drug must pass Phase 2 in order to proceed to Phase 3.
Most reports of medical treatment studies focus on Phase 3 trials. These large trials are required for a drug or other treatment to receive approval for use. The purpose of this phase is to test efficacy and safety, as well as to monitor for side effects. A drug’s main effects are often called the trial’s primary efficacy endpoints. Other measurements are often referred to as secondary endpoints.
Sometimes researchers conduct Phase 4 trials after a drug has been approved. These trials collect additional information about the drug or treatment.
Where to Find Out About Prostate Cancer Clinical Trials
Several sources can be used to find out more about prostate cancer studies going on today. These include the National Cancer Institute (www.cancer.gov/clinicaltrials) and the National Institutes of Health Clinical Trial Resource (www.clinicaltrials.gov). The Prostate Cancer Foundation also maintains a page on its website dedicated to updating patients on the latest prostate cancer clinical trials.
Be sure to continue to follow Prostate Cancer News Today’s continuing series on prostate cancer clinical trials. Our next article will explore the topic of Reasons to Participate in a Prostate Cancer Clinical Trial.