ClinicalTrials.gov is a web site developed and managed by the National Institutes of Health that is gradually accumulating information about ongoing clinical trials from all around the world in every disease you can imagine. In addition, it is also adding links to the site to provide information about the results of completed clinical trials.
For the prostate cancer patient (and for the patient who is trying to prevent himself from getting prostate cancer), the great value of this site is that it can tell you about a vast range of completed, recent, ongoing, and development-stage clinical trials in almost any aspect of prostate cancer.
It can let you know about trials of specific new drugs. It can tell you the category of the trials: Phase I (very early stage); Phase II; Phase III (proof of clinical value); and Phase IV (post-approval trials). It can tell you at what clinical centers you can enroll in such trials. It can tell you whether the study is being carried out at just one center or at multiple centers around the country (or even around the world). Last but not least, it can help you tell understand whether or not you might be eligible for this trial.
The web site can provide you with a vast range of information once you have learned how to use it, and it is not our goal to give you a complete course on the site. However, we do want to show you basically how it works.
First, open the web site by clicking here. (The ClinicalTrials.gov site will open in a separate window so that you can go on following these instructions if you need them.) Then click on the words “Search for clinical trials.” You will get a screen that looks like this:
Enter the words “prostate AND cancer AND prevention” into the search box and click on the word Search. This will bring up the following screen, which contains links to just over 100 clinical trials that have or are investigating different possible ways to prevent prostate cancer:
Now click on the sixth trial in the list, “Long-term follow-up study of … on a Prostate Cancer Prevention Trial.” This is a follow-up trial addressing long-term evaluation of over 2,000 of the patients originally included in the Prostate Cancer Prevention Trial (discussed elsewhere on this site). You will get to this page:
If you look carefully through the information about this trial (which is still recruiting patients), you will see just how much information is provided, and this is just one of thousands and thousands of clinical trials that you can learn about on this site.
As one other example, try entering the words “prostate AND cancer AND Provenge” into the site’s search page. You will get to information about all the studies (completed, ongoing, and still recruiting) that are relevant to the use of the immunotherapeutic agent Provenge (sipuleucel-T). The US Food & Drug Administration (FDA) initially refused to permit the marketing of this drug based on the clinical data available at an advisory meeting in early 2007. In early 2010, the FDA approved the use of sipuleucel-T for the treatment of selected patients with castration-resistant prostate cancer, based on the results of the IMPACT trial. The full results of this trial were published in the New England Journal of Medicine in July 2010. Other trials of sipuleucel-T in the treatment of prostate cancer are ongoing.