The decision to enroll in a clinical trial should involve a discussion between the patient with benign prostatic hyperplasia (BPH) and his or her physician. Participation will depend on many factors, including a person’s motivation for enrolling in a trial, the stage of BPH in a patient, and the trials available.

Different Types of BPH Studies

There are many different reasons why researchers conduct BPH clinical trials. These can include:

• Testing a therapy, such as a drug or other medical intervention, for treating existing BPH. These are known as interventional trials.
• Finding ways to stop the development of BPH, including changes in lifestyle, diet, or medications. These are called prevention trials.
• Evaluating ways to better diagnose BPH. These are referred to as diagnostic and screening trials.
• Studying BPH in a large group of people to better understand it as a health issue. This is known as an observational trial or a noninterventional study.
• Examining ways to improve the comfort and quality of life for people with BPH. 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.

 Phases of Interventional Trials

Interventional trials in BPH, while the most common type of study undertaken by researchers, have 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 BPH 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.

Be sure to continue to follow BPH New’s continuing series on BPH clinical trials. Our next article will explore the topic of Reasons to Participate in a BPH Clinical Trial.

Note: BPH News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.