|Many of the new therapies for prostate cancer are being tested in clinical trials.
Clinical trials are organized studies conducted in patients and are required by the FDA before a particular treatment can be made available to the public.
- Answer specific questions about new treatments.
- Test new ways of using established treatments.
- Test the safety and effectiveness of a treatment.
Every clinical trial is designed to answer a specific set of questions about a treatment. Each study enrolls patients with certain types and stages of cancer and certain health status. If you fit the criteria for a clinical trial, you may be eligible to take part.
You would most likely be referred to a trial by your own doctor or by a doctor who knows your case. You must have a reasonable understanding of the possible risks and benefits of a clinical trial and be freely willing to take part in it. All patients in clinical trials are carefully monitored during and after participating in the trial.
Be sure to talk to your doctor about whether you would be eligible to participate in a clinical trial.
Clinical trials are carried out in phases, each designed to find out a certain type of information about a particular treatment. Information from each phase is built upon in the next phase; all of the information collected on the treatment is used to obtain approval from the FDA for its use.
Phase I Trial
- Involves a small number of patients
- Tests how to give a treatment and how much can be given
- Identifies any side effects caused by the treatment
Phase II Trial
- Involves 20-50 patients with a particular stage or type of cancer
- Tests the effectiveness of the treatment in treating cancer
- Determines the frequency of side effects caused by the treatment
Phase III Trial
- Involves large numbers of patients (in the thousands)
- Compares the effectiveness and side effects of a standard treatment and the new treatment in treating cancer
Patients in these trials are assigned randomly to receive one of the treatments being studied.
Food and Drug Administration (FDA): The U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices.
Clinical Trials: Determine whether new drugs or treatments are both safe and effective in patients.
Protocol: A study plan carefully designed to safeguard the health of the participants as well as answer specific research questions.
Informed Consent: The process of learning the key facts about a clinical trial before deciding whether or not to participate.
Experimental Drug: A drug that is not FDA-licensed for use in humans, or as a treatment for a particular condition.
Standard Treatment: Treatments currently in widespread use and approved by the FDA; considered to be effective in the treatment of a specific disease or condition.
Phase I Trials: Initial studies to determine drug safety and effective in humans.
Phase II Trials: Controlled clinical studies conducted to evaluate the effectiveness of drugs for a particular indication(s) in patients with the disease or condition under study and to determine the common short-term side effects and risks.
Phase III Trials: Expanded controlled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling.