Prostate Cancer

Prostate Cancer Clinical Trials

A clinical trial is a study of a new drug or treatment conducted to test its safety and effectiveness before it is approved by the Food and Drug Administration (FDA) or widely used as standard of care. There are three main phases of clinical trials:

• Phase I studies try to determine safe and therapeutic dosage levels with relatively small numbers of patients
• Phase II trials have more patients to determine whether the new agent is beneficial
• Phase III trials have a large group of patients who receive the experimental treatment and the results are compared with results from a control group receiving standard therapy

Clinical trials are conducted at local cancer centers, including the UCSF Helen Diller Family Comprehensive Cancer Center, as well as at centers nationwide. Participants often are actively recruited. Clinical trials can offer hope but have their risks as well. Any patient considering participating in a trial should ask a number of questions, such as:

• Do I fit the criteria for inclusion?
• How might I benefit from participating?
• What are the probable side effects?
• What if I'm placed in the control group that doesn't get the treatment or medication?

Some promising new approaches for treating prostate cancer include:

• Dendritic Cell Vaccine — Dendritic cells in the blood identify foreign cells or organisms that should be attacked by killer cells of the immune system. In the vaccine approach, dendritic cells are taken from the bloodstream and exposed to the prostate cancer cells. This exposure to cancer cells makes it easier for the dendritic cells to identify cancer cells in the body. After this procedure, dendritic cells are inserted back into the blood stream to target prostate cancer cells for immune system action.
• Monoclonal Antibodies — These are agents that are developed to trigger an immune system response by targeting antigens that are present on the surface of prostate cancer cells.
• Genetically Engineered Viruses — Viruses such as the common cold virus are genetically modified to target prostate cancer cells. These viruses can be injected directly into the prostate or into metastatic tumors.
• Chemotherapy — A traditional chemotherapy drug can be combined with a protein-like compound and is released only when it comes in contact with prostate cancer cells, selectively targeting them for attack.
• Anti-Angiogenesis — At some point, cancers need to develop a blood supply if they are to grow. New agents are being developed and tested for their effectiveness in slowing the growth of blood vessels in tumors.
• Radiation Therapy — There are trials to evaluate modifications in the delivery of radiation therapy, or to discover how radiation therapy can be combined with other therapies to more effectively treat higher-risk prostate cancers.
• Diet and Life Style Changes — Dr. Dean Ornish, who developed a program that successfully treats serious cardiovascular disease, is studying whether a similar program can slow or reverse early-stage prostate cancer. The program includes: adhering to a very low fat, vegetarian diet; nutritional supplements; regular exercise; stress reduction and group support.
• Nutritional Supplements — Past research has shown that certain tomato-based foods and marine fatty acids may contribute to primary prevention and possibly progression of prostate cancer. The UCSF Molecular Effects of Nutrition Supplements (MENS) Prostate Study is currently researching how the nutritional supplements – lycopene (tomato extract) and fish oil – affect the prostate tissue microenviroment.

To view a full listing of current prostate cancer clinical trials, visit the UCSF Helen Diller Family Comprehensive Cancer Center Clinical Trial Web site.

Reviewed by health care specialists at UCSF Medical Center.
Last updated November 18, 2007

This information is for educational purposes only and is not intended to replace the advice of your doctor or health care provider. We encourage you to discuss with your doctor any questions or concerns you may have.