Finding out about clinical trials

Participating in clinical trials of new drugs, new methods, and new diagnostic tools is one of the ways prostate cancer patients and men at risk for prostate cancer can help to move us toward the point at which prostate becomes both preventable and curable. For each specific trial there are going to be some really crucial things that you need to understand before you jump in with both feet!

So, if you have never done this before and you want to either do it or think about doing it, you really need to do at least some homework first!

What we have given you here is a list of things that you would probably be wise to ask about any clinical trial you are invited to take part in (or that you are trying to find out more about):

Questions about the trial itself

  • What is the goal of this particular trial?
  • Why do people think that the drug or procedure being tested may be effective? Has anyone ever tested it before (in prostate cancer or in other forms of cancer)?
  • Who is overseeing the study, and who is paying for it? It there a commercial sponsor or is this study being done with federal funds or some sort of grant?
  • Who has reviewed the study to make sure it meets ethical and clinical guidelines for good practice?
  • How do I know that the researchers and other study personnel have appropriate qualifications to do this study?
  • Who is responsible for making sure that the safety of participants is being carefully monitored?
  • How long will the study last, and how long will I personally need to participate?
  • When will everyone know the results?
  • If you were in my situation, doctor, is this a trial you would participate in?

Questions about possible risks and benefits of participation

  • Are there any possible short-term benefits? If so, what are they?
  • Are the any possible long-term benefits? Again, if so, what are they?
  • What are known the short-term risks, such as side effects?
  • What are the known long-term risks?
  • Are other treatment options available that might be more appropriate for me? 
  • How do the possible risks and benefits of this trial compare with those of other options?

Questions about participation in the trial and the the care you would receive

  • What treatments, medical tests, or procedures will I get during the trial, and often will I need to receive them?
  • Will any of the treatments, tests, or procedures be painful? If so, can the pain be controlled, and who will be responsible for my care if the pain is not contollable?
  • How do the tests and procedures compare with what I might receive if I wasn’t involved in the trial?
  • Will I be able to take my other, normal regular medications if I take part in this trial?
  • Where will I need to go to take part in this trial? Will I have to be in a hospital? If so, for how long?
  • Who will be in charge of my care? Will I still be able to see my own doctor?
  • How long will I need to take part in the study?
  • Will there be follow-up visits needed after the initial phase of the trial? If so, for how long?

Personal Issues

  • Will taking part in this trial affect my daily life? For example, will I have to go somewhere for daily treatment for several hours?
  • What other forms of help are available for me and my families? For example, is there assistance with essential travel costs?
  • Is it possible for me (and my wife) to talk with people already enrolled in the study so we can get other patients’ views directly?

Cost issues

  • Will I have to pay for any of the treatment, tests, and procedures, or are they covered by the trial sponsor? If I do have to pay for any of the costs, roughly how much will they be?
  • Is my health insurance likely to cover costs that aren’t being covered by the trial sponsor?
  • Will you, or someone else involved in the trial organization help answer any questions from my health insurance company or health plan?

There are also going to be questions that need answers that will be specific to each trial. Our goal here is only to give you a sense of what you need to learn before you commit yourself to any specific clinical trial.

Once you have learned how to use ClinicalTrials.gov, you will be able to find out about all the clinical trials that are going on in prostate cancer. You can also get information that may be helpful by “signing up” with companies like Nexcura and CenterWatch that specialize in helping to recruit patients to clinical trials. Not only can they provide you with detailed information about those trials, in many cases they will also be able to help you to get answers to questions like the ones outlined above.

Content on this page last reviewed and updated April 6, 2008.
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