Johns Hopkins Health Alerts | Prostate Disorders | Joining a Clinical Trial

Michael A. Carducci, M.D. , Associate Professor of Oncology and Urology at Johns Hopkins, explains why you might want to enroll in a clinical trial if you have advanced prostate cancer.

Even though all patients want therapies that will keep their cancer in check, it is estimated that only 3% of the possible number of people who would be candidates for clinical trials of novel cancer agents actually enroll in clinical trials. What will help push the science forward at a greater pace is having more men enroll in clinical trials of experimental prostate cancer therapies.

You might want to join a clinical trial for a number of reasons, for example:

• If you have advanced prostate cancer, you might hope for remission, or even for a cure.
• You might see participation in a clinical trial as providing access to free, high-quality treatment.
• You might be altruistic and simply want to help advance medical knowledge through participation in a clinical trial.

Clinical trials also provide answers to more basic questions that are vital when developing a new drug: Can an injection get the medicine to you faster than a pill? Does the newest painkiller make you less drowsy than the others?

The engine of medical progress depends on data from clinical trials for fuel, but getting the best data requires the willing participation of hundreds or thousands of people. Here's how a study works. Studies always begin in test tubes and in animals. If results are promising, patient recruitment begins for the different phases of the study.

• Phase I clinical trial evaluates drug safety in a few dozen subjects with advanced disease, determines dosage, and identifies side effects.
• Phase II clinical trial involves up to a few hundred participants, but is typically small -- in the range of 30 to 40 patients.
• Phase III clinical trial gathers more definitive results by determining benefits and risks in a larger number of people. Hundreds or thousands more people are enrolled, and treatment results are measured against placebo or existing treatments.
• Phase IV clinical trial occurs after the FDA approves the medication and it becomes available to the public, usually by prescription. This phase examines long-term effectiveness and side effects.

Bottom line advice: To find a clinical trial of an investigational medication for advanced prostate cancer, contact your local hospital or medical center, or ask your doctor to help. Be wary of claims in advertisements, and make sure your health costs are covered. The following groups can help direct you to clinical trial of novel prostate cancer therapies. If you meet enrollment qualifications, you can also enroll in one of the several ongoing studies at Johns Hopkins.

National Institutes of Health Phone: 888-346-3656 www.clinicaltrials.gov

Centerwatch Inc. Phone: 800-765-9647 www.centerwatch.com/patient

Johns Hopkins University School of Medicine, Clinical Trials Unit Phone: 410-955-7669 www.hopkinsclinicaltrials.com

Sidney Kimmel Comprehensive Cancer Center Phone: 410-955-8804 www.hopkinskimmelcancercenter. org/clinicaltrials

Johns Hopkins Health Alerts | Prostate Disorders | Joining a Clinical Trial