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New Prostate Cancer Tests Create Treatment Dilemmas
By Food and Drug Administration (FDA)

The names are familiar: actors Don Ameche, Bill Bixby, and Telly Savalas, entertainment mogul Steve Ross, rock musician Frank Zappa. Though show business links these men, they share another connection. Each has died of prostate cancer.

If there's a silver lining to be found amid the clouds of these tragic deaths, it is that the fame of these men has helped spotlight a disease that now ranks as the second most common cancer men get — after skin cancer. The American Cancer Society says prostate cancer will strike 334,500 U.S. men in 1997, twice the number of male lung cancer cases. Some 41,800 will die. One out of every five American men will develop prostate cancer in their lifetime.

Public notice is something new to prostate cancer. For years, men didn't worry much about the disease. They typically thought of it as a slow-moving condition that affects men well past retirement, when they are likely to die of something else before succumbing to cancer. In many cases, that's still true. Most cases are in men 65 and older. But like Bixby, who was 59 when he died, and Zappa, who was 52, younger men also can fall victim.

Experts say the recent increase in reported cases can be attributed to new tests that make detection easier. Longer male lifespans also may play a part. With today's methods, men who otherwise would be unaware of their cancer are learning sooner they have the disease. Thus, reported cases rise. Still undetermined, however, is whether improved early detection will reduce prostate cancer's mortality rate.

A walnut-sized gland tucked away under the bladder and adjacent to the rectum, the prostate provides about a third of the fluid that propels sperm through the urethra and out of the penis during sex. Many males are what one cancer survivor called "abysmally ignorant" about where the prostate is and what it does. Also, health officials say, men tend to dismiss troubles related to their sex organs, so they may shy away from seeing a doctor, even after disease symptoms appear.

Though prostate cancer historically has kept a low profile, its visibility is rapidly changing. Like breast cancer a decade ago, prostate cancer suddenly is a topic on talk shows and in newspaper and magazine articles. Support groups now number over 300 nationwide. Screening booths are popping up at state fairs and shopping malls. Famous people are going public. Sen. Jesse Helms, and former Sen. Bob Dole have openly discussed their prostate cancer treatments. Others who have publicly fought the disease include retired Gen. H. Norman Schwarzkopf, Supreme Court Justice John Paul Stevens, comedian Jerry Lewis, and former financier Michael Milken.

Early Detection

All the attention, along with new scientific information, is contributing to a growing quandary for doctors and patients over how best to manage the disease. A relatively new blood test called the prostate specific antigen (PSA) test has increased early detection odds considerably. But the test alone cannot determine if a man has prostate cancer.

The PSA test measures a protein made only by the prostate. In all healthy men, a small amount of PSA protein passes into the bloodstream from the prostate. If a man's prostate becomes enlarged, it may secrete increased amounts of PSA, creating higher blood levels of the protein. This also may occur when infection damages the prostate lining and allows more than normal PSA amounts to be released. Prostate cancer itself may produce increased PSA levels. Though the PSA test may be the first step toward a cancer diagnosis, elevated PSA levels may signal conditions other than cancer. These include benign prostatic hyperplasia (BPH) and an infection called prostatitis (see accompanying article).

"What the PSA test does is alert the physician that a man may have something wrong with his prostate,'' says Max Robinowitz, M.D., medical officer in FDA's Center for Devices and Radiological Health. "The doctor then must decide if more testing is needed to identify the problem."

Since 1985, FDA has approved several PSA tests for monitoring possible recurrence of prostate cancer in men being treated for the disease. The PSA method is not intended for mass screening of men with no symptoms.

First Approval

In August 1994, FDA approved the Hybritech Tandem PSA Assay, the first test the agency has sanctioned to help doctors detect prostate tumors in patients with or without symptoms who are suspected prostate cancer risks. FDA specifies that the Hybritech test be used with the traditional test for screening prostate cancer, the digital rectal exam (DRE). Physicians perform the DRE by inserting a lubricated, rubber-gloved finger into the rectum, where they can probe the prostate for lumps or enlargements that may indicate prostate or even rectal tumors.

The American Cancer Society and American Urological Association recommend annual PSA tests for men over 50 and for high-risk men over 40. Men at increased risk include African Americans, whose incidence of prostate cancer is about 30 percent higher than that of whites, and those with urinary tract symptoms or who are genetically predisposed to the disease. Study data show that if a man's brother and father had prostate cancer, he may have as much as an l1-fold increase in risk and may be stricken before age 50. The National Cancer Institute is sponsoring a trial to find out whether extensive prostate cancer screening, as well as earlier detection and treatment, can improve survival rates.

PSA tests are simple, noninvasive, and cost $30 to $70. They are, however, not perfect. Doctors interpret cancer potential based on whether PSA results are elevated, a level usually defined as above 4 nanograms of the protein per milliliter of blood (ng/mL). But noncancerous conditions can increase this level. Also, a certain percentage of men with prostate cancer, such as those taking drugs for BPH, will show low or "normal" PSA amounts.

"A patient may have an elevated PSA test, but this doesn't mean he has prostate cancer," says Peter Maxim, Ph.D., who heads FDA's immunology branch. He adds that it's always best to use the DRE and PSA tests together to achieve maximum benefit. Despite drawbacks with both techniques, more than 50 percent of men referred for further testing have prostate tumors, says the American Cancer Society.

Next: Part 2

Tags: Prostate Cancer

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.


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