Friday, May 30, 2008

FDA Approves Phase 2 Trial for Prostate Cancer Vaccine



The FDA has approved Phase II clinical trials to measure the effectiveness of Ad/PSA (adenovirus/prostate-specific antigen), a vaccine that could help men fight prostate cancer. The first trial has lead David M. Lubaroff, MD, lead investigator of the study, to become “cautiously optimistic” about the benefit of the vaccine for extending and improving quality of life for men with advanced disease. Dr. Lubaroff is professor of urology and microbiology and associate director of the Holden Comprehensive Cancer Center at the University of Iowa, in Iowa City. He presented the findings during the American Urological Association’s 2008 Annual Meeting.

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The study involved 32 men who had metastatic prostate cancer. The group received one of three doses of Ad/PSA vaccine, produced by inserting PSA gene into bacteria and viruses, and using immune-stimulatory DNA to help the body search and destroy tumors. The vaccine was successful in producing cancer antibodies in 42% of the group, anti-PSA T-cell responses in 71%, and immune responses in 40% of the patients tested. Predicted survival rate increased in 57% of the men; the longest survival was 71 months. The Phase 2 trial is expected to be completed by December 2010. The first round of testing for prostate cancer vaccine has produced powerful results. The upcoming trial is seeking 82 participants.


Estimates show that 1 in 44 in men aged 40-59 years and 1 in 7 in men aged 60-79 years will develop prostate cancer. The risk increases with age, and the risk for African-Americans is 1.5 times greater than other ethnic groups. Elevated PSA levels are associated with localized and advanced prostate cancer, though the effectiveness of blood testing has been questioned in past studies. A combination of current screening methods and biopsy continue to be the best recommendations for early detection.

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According to the National Cancer Institute, “in 2007, an estimated 220,000 men will be newly diagnosed with prostate cancer in the United States and about 28,000 men will die from the disease."A focus on prevention includes awareness of family history and lifestyle modification for prevention. Data from the Health Professionals Follow-Up Study, performed on men age 40 to 75, showed that consuming a lycopene rich diet can reduce the risk of prostate cancer by 35%, and decrease the chance of advanced prostate cancer by 54%. Tomato sauce is rich in lycopenes. Men who consumed two servings a week reduced their chances of developing prostate cancer by 23%. Tomato sauce consumption also helped the spread of prostate cancer by 35%. Lycopene supplements were not shown to produce the same results, making whole food choices our best option for disease prevention. A recent study shows that Vitamin E, Beta Carotene or Vitamin A supplements can have an adverse effect on your health, accelerating the growth of cancer and contributing to poor cardiovascular health.

Know your family history and take your risk factors seriously. Engage in regular exercise to keep your weight stable. The link to obesity and many forms of cancers remains the subject of considerable study.

Researchers continue to gain more insight into the mechanisms of prostate cancer. Prevention is your primary defense. Unfortunately, evidence shows that routine screening may cause more harm than good in causing unnecessary anxiety, leading to biopsies that carry genuine risks, including the chance of erectile dysfunction. The evidence just doesn’t support the benefits of routine screening for prostate cancer, though it is the best tool we have, nor has routine screening shown a decline in the incidence of prostate cancer deaths. You should discuss with your doctor the statistics related to false positive PSA testing, and enlist the help of your healthcare provider when making decisions about biopsy.

Early aggressive treatment still provides the best outcomes. Advances in the development of a prostate cancer vaccine should be viewed as nothing short of fantastic, given the current challenges of early detection. We can also hope the findings will lead to new ways to prevent and treat other forms of cancer.

If you are treating or know someone who is suffering from prostate cancer, and are interested in participating in the vaccine study, you can find more information at ClinicalTrials.gov.

Sources: American Urological Association (AUA) 2008 Annual Meeting: Abstract 526. Presented May 18, 2008. ◦
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