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What is a clinical trial? How can it affect my choice of treatments? Are there risks involved? When should I consider going on a clinical trial?

These are all questions that often confront patients with advanced prostate cancer. In this section of our website, we will try to help you understand the facts, benefits and risks involved in clinical trials for new cancer treatments.

In brief, a clinical trial is a carefully managed test of the effectiveness of a new drug or treatment program, using actual volunteer patients as the test subjects.

Clinical trials are normally sponsored (paid for) by a drug company, but almost always they are run by an independent organization such as a university hospital or group of doctors in one or more clinics.

Volunteering for a clinical trial is a serious commitment. In deciding to do so, you should always look at both the potential benefits and the downside associated with the trial. Always consider what impact it may have on your disease, and your survival outlook. Discuss your situation with at least one doctor who knows your history and is NOT participating in the trial as well as those conducting the trial!

On the other hand, as a clinical trial participant, you can take the credit for being a pioneer. No progress in cancer treatment would be made if it were not for those who volunteer for clinical trials. Another advantage of being in a clinical trial is that you will typically receive excellent medical attention from the organization conducting the test, and usually the treatment is completely without cost to you.

To volunteer for a clinical trial, you can contact the sponsoring drug company directly, or get in touch with the organization performing the trial. If you are unsure how to go about this, try asking your oncologist for help.

There are now four levels of clinical trials:

Phase I - Determine the safest and best way to give a new treatment.

• Purpose: determine if and how a new treatment can be given safely to people.
• Supporting information: previous laboratory tests and tests in animals.
• Participants: a limited number of patients who would not be helped by other known treatments.
• Process: use gradually increasing doses while watching for harmful side effects.
• Trial type: open; everyone is aware of treatments used.
  

Phase II - Determine if a treatment has an anticancer effect and which type of cancer it treats best.

• Purpose: discover how effective the treatment is against specific types of cancers.
• Supporting information: safe dosage information from Phase I evaluation.
• Participants: people with various kinds of cancer who have had at least one standard treatment in the past.
• Process: monitor progress of treatment to learn how well certain cancers respond to the new treatment.
• Trial type: generally not randomized.
  

Phase III -Compare the new treatment with standard treatments.

• Purpose: compare the new treatment with standard treatment.
• Supporting information: safety and efficacy results from Phases I and II.
• Participants: patients with the cancer being studied.
• Process: evaluate progress to find advantages and disadvantages over standard treatment.
• Trial type: large, randomized groups; single-blind or double-blind.
  

Phase IV - Refine the treatment and improve management of side effects.

• Phase IV trials start after US Food and Drug Administration (FDA) approval of the drug for general use.
• Purpose: refine the details of the treatment plan; reduce and help manage side effects.
• Supporting information: dosage, effectiveness, and other information from Phases I through III.
• Participants: patients whose doctors prescribe the treatment.
• Process: measure and evaluate effectiveness with larger numbers of patients; monitor number and severity of side effects; evaluate the management of side effects.
  

Pharmacia Corporation has an excellent brochure (in PDF format) on clinical trials which covers most common questions - click here to see or download it.

There is also a website sponsored by the National Institutes of Health which gives a very good description of available clinical trials through a search engine - click here.

The National Cancer Institute also has some very helpful information on clinical trials - click here.