Clinical trials are essential for the development of new, safer, and more effective treatments. Trials have not only advanced our knowledge, they offer hope for the future for all men. Without trials we could not evaluate whether a new treatment works, if it is just “snake oil,” or even if it is even safe.
Participating in a trial can benefit you now and it will benefit others as well as yourself in the future.
I don’t care about research…I am in this clinical trial to get the latest treatment and the best chance I have of living longer
Clinical trials offer great hope, but they also present some risk. When deciding if you are willing to participate in a trial you must learn about the possible benefits and the possible risks to which you might be subjected.
There has been significant prior study of the investigation product before any drug or treatment makes it to a clinical trial on humans. There have been pre‐clinical trials (bench science) and animal studies that lead up to the trial.
Before deciding to participate in a trial you should speak with your doctor as well as the clinical trial coordinator and ask;
- Is there strong evidence that this treatment could work for me?
- Is it a randomized trial?
- If it is randomized is there a chance I could get a placebo, or are all groups going to receive the investigation treatment?
- What are the risks and what are the benefits of my participating?
- If I do well on the investigation treatment will I be able to continue to receive it even after the trial has ended?
- If I receive the placebo will the trial protocol allow me to “crossover” and receive the investigational treatment if I so desire?
- What additional commitments will be required of me if I participate in the trial? Will there be additional tests or scans, doctor or hospital visits required? It’s important to make sure that you fully understand how much extra time and effort will be required from you.
- To what additional financial costs will I be obligated? Usually, the researchers will pay for the research costs, but you or your insurance company might remain responsible for your routine patient care costs. Check with and make sure that your insurance company will pay for these costs while you are on an experimental therapy.
- If you change your mind about participating, or you believe that the trial is not working for you, you always have the right to withdraw from the study at any time.
When Should I Participate In A Trial?
There are appropriate trials for prostate cancer at all stages of disease progression. Many of us look to trials only when we feel there are no alternative treatments available to us. Trials are important at all stages and you should consider participating in one even if there are still treatment options open to you.
Trials are a way to get cutting edge treatment before anyone else.
What Are The Different Trial Phases?
Clinical trial research progresses in an orderly series of steps, called phases. The phasing of trials allows researchers to ask and answer questions in a manner that results in reliable information about the investigation drug or treatment, while also protecting the patient. Clinical trials are classified into one of three phases:
Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into muscle), how often, and what dosage is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
Phase II trials: A phase ll trial continues to test the safety of the new drug, and begins to evaluate how well it works. Phase II studies usually focus on a particular type of cancer.
Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure, in comparison with the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted and coordinated at many doctors’ offices, clinics, and cancer centers nationwide. They are also used to determine precise recommended dosages.
After a treatment has been approved and is being marketed, the drug’s maker may study it further in a phase IV trial. The purpose of phase IV trials is to evaluate side effects, risks, and the benefits of the drug over a longer period of time and in a larger number of people than in phase III clinical trials. Thousands of people are involved in a phase IV trial. (http://www.cancer.gov
You can read Malecare’s frequently asked question guide about clinical trials at: https://malecare.org
You can search Malecare’s up to date prostate cancer clinical trial directory at http://www.centerwatch.com/ctrc/malecare/