Senate Subcommittee on Aging

September 23, 1997

E. David Crawford, M.D.

Chairman, National Prostate Cancer Education Council

Associate Director, University of Colorado Cancer Center

Prostate cancer represents a male epidemic. During 1997, it is projected that over 200,000 men will be diagnosed with prostate cancer --- and 41,000 will die as a direct result of the disease. In the past 15 years, the number of new cases of prostate cancer diagnosed has increased by three-fold. Less than seven years ago, greater than 80% of the cases of prostate cancer diagnosed were advanced, and therefore incurable. During this presentation, I will explain why testing for prostate cancer is important as well as discuss the urgent need for research support.

Faced with these previously mentioned grim statistics regarding the rising incidence and mortality from prostate cancer, there are a number of possible strategies to pursue. One can bury his head in the sand and ignore the problem, citing the fact that prostate cancer is usually a disease of older men, and you "have to die of something". Others might rationalize that our healthcare system cannot afford to deal with this disease because there are so many other pressing issues such as AIDS, childhood immunizations, smoking cessation, etc. In fact, during a trip to Europe just two weeks ago, I found that many countries subscribe to the latter way of thinking.

A second strategy is to try to prevent the disease. Ideally, this would be the optimal solution. In the past decade, we have learned a lot about what causes prostate cancer. This knowledge leads to strategies to alter its initiation. If we

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examine the worldwide incidence of the disease, we see that it is extremely low in Japan, China, and other Oriental cultures. Yet when you examine the US incidence, it is dramatically increased -- especially in African-American males -- why?

A Western diet which is high in fat plays a major role in the development of prostate cancer, since when men from countries with a low incidence move to the United States and partake of our diet, their incidence of prostate cancer dramatically increases.

Table I

Worldwide Age-Adjusted

Prostate Cancer Death Rates

per 100,000 Population

Recently, there have been reports of a reduced incidence of prostate cancer in men consuming tomato products, soy, vitamin E, selenium, and other items in our food chain. These findings offer exciting leads to see if adding one or more of these substances to our natural diet will decrease the risk of prostate cancer. I believe there exists a lot of exciting potential in preventing prostate cancer -- but unfortunately, even if we knew how to prevent prostate

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cancer today, it would be many years before a positive impact would occur on either the incidence or mortality rates. And why do African-Americans have such an alarmingly high rate of prostate cancer and increased mortality? In some cases it is due to the lack of access to healthcare, but many other factors are emerging through research in the area. It is critical that we understand these, factors if we are to change the high incidence and death rate from prostate cancer experienced by African-Americans.

A third strategy would be to develop some a cure for advanced prostate cancer. Progress has been made in this area during the last decade, but the "magic bullet" has yet to be discovered. Doctor David McLeod from Walter Reed Army Medical Center will talk about a large, randomized clinical trial that we performed in advanced prostate cancer, where the simple addition of a well-tolerated oral antiandrogen (Eulexin) improved survival in this fatal disease by 26%. Recently it has also been reported that a well-tolerated chemotherapy drug called Mitozantrone can improve the quality of life in men dying of dying of prostate cancer. Neither one of these treatments represents a cure; however, as I travel around the world to visit research centers, it is apparent that significant potential exists. I have become very optimistic that progress is being made which will either cure many patients with advanced prostate cancer, or at least slow its growth.

The fourth strategy, and one with the most immediate benefit, is to find it early, treat it, and to cure it. In 1988, we did a survey of several hundred men over the age of 40 -- asking questions about whether or not they had a regular physical exam, and what they talked about with their physician. Surprisingly, less than 50% of men had a physical exam within the last two years, and -- of greater concern -- of those who did, less than half of their physicians had performed a rectal exam to attempt to detect prostate cancer.

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In 1989, prostate cancer became the most common cancer diagnosed in American males, surpassing lung cancer in incidence. That same year, we formed the Prostate Cancer Education Council to try to inform men about how common prostate cancer was and to try to encourage early diagnosis. One of the first challenges was to try to find a national spokesperson. We couldn't find a prominent male with prostate cancer who was willing to help us. However, former Pittsburgh Steeler running back, Rocky Bleyer, agreed to help that year -- primarily because his grandfather had prostate cancer. We utilized Mr. Bleyer to generate national media coverage and launch Prostate Cancer Awareness Week the last week of September, 1989. During that Prostate Cancer Awareness Week, nearly 10,000 men visited sites around the country to find out about prostate cancer, as well as to undergo early detection with a rectal examination. We did attract a lot of media attention, and it appeared that men were starving for information about prostate cancer.

The growth of Prostate Cancer Awareness Week has been phenomenal. We have been able to secure the help of a number of prominent spokespersons, including Norman Schwarzkopf and (for this year) Harry Belafonte. In the past seven years, over three million men have been screened during Prostate Cancer Awareness Week. Millions of others have requested examination because of the publicity generated. The American Urological Association, the American Foundation for Urological Diseases, and the American Cancer Society have all contributed to prostate cancer awareness.

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Vital information has been accumulated since our initial Awareness Week in 1989. We found that a simple blood test known as PSA (prostate specific antigen) was capable of detecting cancers and at an early curable stage. We discovered that the combination of an abnormal PSA blood test and abnormal rectal exam (DRE) had a 50% predictive value for the presence of prostate cancer.

See Table 3

This compares very favorably to an accepted screening modality, mammography for breast cancer detection. The predictive value for mammography is only 20%. Through careful analysis of our data, as well as that of others, we have improved the sensitivity of testing to detect the disease while reducing false negative results. Recently, different forms of the PSA blood test have been discovered which has further refined our diagnostic accuracy. We've learned to screen for prostate cancer beginning at age 40 in higher-risk groups such as African-Americans and those individuals with a family history of the disease. Finally, we have the virtually eliminated advanced incurable prostate cancer in men who participate in annual screening. Screening for prostate cancer has been shown to be cost-effective compared to the financial outlays to detect breast and a number of other cancers.

See Table 4

In spite of all this good news, there is controversy about the value of screening. A number of prestigious organizations do not endorse screening, yet they do not deny that it might be beneficial

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I believe that in order to comprehend their position, it is necessary to separate the components of concern. No one can deny that early detection detects early and potentially curable cases of prostate cancer. Early detection is associated with some financial implications, but it is not prohibitive, and falls within cost parameters to detect other cancers, including breast cancer. Through early detection we have reduced or eliminated the presence of advanced, incurable prostate cancer.

The real area of controversy is in the value and side effects of treatment. I believe that if you find and treat an early prostate cancer in a man with a ten-year life expectancy, you can extend his life. Unfortunately, we do not have a randomized clinical trial which proves my conviction. Unlike breast cancer, where research support existed in the early 1960s for studies which ultimately showed a survival benefit, we don't have these in prostate cancer. At the University of Colorado, we are participating in a large and important National Institutes of Health-sponsored trial called the PLCO (prostate, lung, colorectal, ovarian) Cancer Screening Trial The purpose of this study is to establish the value of early detection. It will be many years (perhaps 10-15) before we know the results of this pivotal study. Because we do not know the value of early detection on ultimate mortality, we have established a motto for Prostate Cancer Awareness Week which states that "men should be able to choose to know in order to know to choose their treatment". Once they have the reassurance of knowing whether or not they have prostate cancer, they can make an informed decision. If a diagnosis of prostate cancer is made, options from simple watchful waiting to surgery or radiation can be considered. It is discouraging to see many men who are refused the opportunity to have a PSA test and rectal exam. In order to deal with this challenge, three and a half years ago, legislation was enacted in the state of Colorado which mandates the PSA test be covered by health insurance carriers. We need this coverage on a nationwide basis, and

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your efforts to provide this coverage through Medicare is important.

We need significant research support to evaluate and improve our results, as well as the side effects from treatment.

In summary, there is a good and bad news about prostate cancer. The good news is that there has been an intense public focus concerning the disease. At least for those men who undergo early detection, we have drastically changed the grim statistics regarding their chance of developing an incurable cancer. Because prostate cancer is so common, more researchers are interested in finding a cure, prolonging survival, and eliminating the pain and suffering that accompanies the disease.

The bad news is that men are still reluctant to declare war on prostate cancer. We haven't been able to get significant numbers of African-Americans to participate in early detection when compared to Caucasians. Men still die seven years earlier than women, and make one-quarter as many doctor visits. We don't have enough research dollars to effectively combat this disease. Increased research moneys will result in a rapid development of a cure. These moneys are necessary in the arena of prevention, early detection, cure of advanced disease. In 1989, when we first began to talk about this lack of research support, less than $10 million were allocated for prostate cancer research. During 1990 to 1997, $376 million have been directed toward prostate cancer research -- and over $1.8 billion for breast cancer.

See Tables 5 and 6

I believe that every dollar (and even more!) allocated for breast cancer research is deserved -- but I also believe that what is currently happening relative to prostate cancer research borders on insult to American males, especially

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those of African-American descent. We need support for programs like Prostate Cancer Awareness Week. It currently costs less than $200,000 a year to support the awareness week, which is minuscule when one examines its overall impact. We need at least $500,000 per year to continue this Prostate Cancer Awareness Week under the auspices of the Prostate Cancer Education Council. These moneys will permit us to expand successful promotional efforts, and to analyze and add to our tremendous database.

Researchers become frustrated when great ideas in science exist, when months are spent writing grant applications, and then learn there is less than a 20% chance of any funding. A great deal of what occurs with this disease in the next decade is dependent on the research dollars that are available for education, detection, and treatment. I sincerely request your assistance on behalf of the American male.

Thank you.