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Prostate Cancer New Tests Create Treatment Dilemmas (FDA Consumer Prostate Cancer: New Tests Create Treatment Dilemmas (FDA Consumer Reprint)
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[U.S. Food and Drug Administration]

This article originally appeared in the December 1994 FDA Consumer.
The version below is from a reprint of the original article and contains revisions made in July 1997.

Prostate Cancer:
New Tests Create Treatment Dilemmas

by John Henkel

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.

illustration of digital rectal examination 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.

Making Sure

Doctors follow up an elevated PSA or positive DRE with more definitive testing. Some physicians employ transrectal ultrasound (TRUS), which uses a rectal probe that creates a video image of the prostate using harmless sound waves collected by a computer. TRUS helps the physician "map" uneven areas of firmness in the prostate, and it can help a doctor decide if a biopsy is needed. If so, the doctor will take tiny prostate tissue samples with a small-gauge needle, injected typically through the rectum. Another physician, a pathologist, then examines the samples under a microscope.

"No surgery or other anti-cancer therapy is done without first ensuring with a biopsy that a patient has cancer and not some other condition that can cause symptoms and other suspicious signs," says FDA's Robinowitz. Once cancer is diagnosed, other tests such as computerized tomography, lymph-node biopsies, and bone scans can determine if tumors have spread beyond the prostate.

For cancer confined to the prostate, opinions are split over what to do. Orthodox wisdom holds that cancer should be treated aggressively. With prostate cancer, this means removing the gland (radical prostatectomy) or bombarding it with radiation. Experts say these options may offer good prospects for curing the disease if exercised early enough. Treatment choice usually depends on what specialist the patient consults. Urologists tend to recommend surgery while oncologists generally advise radiation therapy.

Surgery may cause unpleasant adverse effects. Because radical prostatectomy can result in severing nerves and blood vessels related to sexual or bladder function, the operation in the past has left virtually all patients impotent, incontinent, or both. That is changing, however, thanks to pioneering research done in the 1980s by Patrick Walsh, M.D., urology chairman at Johns Hopkins University Hospital. His "nerve-sparing" surgical technique, which increasing numbers of doctors are adopting, now allows many men to preserve erectile functions. Walsh says his patients under age 50 have about a 90 percent chance of regaining potency, but that number drops to 25 percent for patients in their 70s.

Radiation therapy also has adverse effects, including impotence in about 40 to 50 percent of patients.

For older men with early-stage prostate cancer, a number of physicians are dispensing a different kind of advice: Wait and see.

Doctors clearly are divided on its merits, but this "watchful waiting" philosophy got a boost by a 1994 report in the New England Journal of Medicine. The study analyzed case records of 828 prostate cancer patients treated conservatively (watchful waiting or hormone treatments but no surgery or radiation therapy). It found that 10 years after diagnosis, 87 percent of those with slow-growing, localized prostate tumors still were alive. Of those diagnosed with more aggressive cancer, 34 percent remained alive at the 10-year mark. Supporters say watchful waiting is a practical alternative for men in their late 60s or older, whose lifespans may be limited by advanced age and serious ailments such as heart disease. If treated, these men could suffer the trauma and adverse effects of cancer therapy with little or no benefit.

Not all prostate cancer is equal. One type of tumor may lie dormant for years while another is virulent and deadly. Deciding whether to wait or act can be difficult because physicians often can't judge conclusively which tumors might spread. Size can give some indication. Another gauge, the Gleason system, identifies a tumor's growth potential based on its appearance under the microscope. The system distinguishes progressive grades of prostate cancer on a scale of 2 to 10. Clumped-together cancer cells with well-defined edges are less likely to grow rapidly and are given a low Gleason number. Cells distributed randomly with uneven edges are more apt to spread and receive a high Gleason number.

Also important is "staging"--a predictor of how extensively the disease has grown within or beyond the prostate. This ranges from stage A, where the tumor is still microscopic and confined, to stage D, where cancer has spread to the lymph nodes or to other organs outside the prostate. The lower the staging, the more likely the cancer can be cured. Stage D tumors are rarely curable. The ideal watchful waiting candidate is a man with a low Gleason score and a stage A or B tumor.

Prostate tumors are fueled by male hormones called androgens. Advanced prostate cancer is usually treated with therapy that reduces androgen levels--such as testicle removal or drug/hormone therapy.

Though prostate cancer research has yielded significant advancements in the last decade, there's still a long way to go, says FDA's Robinowitz. "The dilemmas [of treatment] are due to the power of the cancer and the limits to our current knowledge and therapies," he says. "New tests [such as PSA] may be only partial solutions, but they are the best we can do for now."

John Henkel is a staff writer for FDA Consumer.

For More Information

Sources of prostate cancer information and support include:

American Cancer Society
Offers the free brochure "Facts on Prostate Cancer" and other information.

American Foundation for Urologic Diseases
Has a free booklet, "Prostate Cancer: What Every Man Over 40 Should Know," and other materials on cancer and other noncancerous prostate conditions.

National Cancer Institute
Can give information on clinical trials, as well as send "Cancer Facts" and other materialse.

Us Too
Publishes a monthly newsletter for prostate cancer survivors and has local chapters throughout North America.

Other Prostate Disorders

The symptoms can he deceiving. A man may have difficulty urinating or may have frequent and urgent needs to urinate. His prostate specific antigen (PSA) levels may he elevated. These signs could point to prostate cancer. But more often than not, the prostate gland is acting up in less dangerous ways, the most common being benign prostate hyperplasia (BPH).

A disorder in which the prostate enlarges, BPH is not cancer and does not cause cancer. It is much more common than prostate cancer, affecting greater than half of American men in their 60s. Up to 90 percent of men over 80 have some BPH symptoms. Health-care costs or BPH exceed $2 billion a year, according to National Institutes of Health (NIH) estimates.

Doctors can detect the condition through a digital rectal exam. Other tests can determine severity. Because the prostate surrounds the urethra, any enlargement can choke off urine flow. Sometimes the prostate is only mildly enlarged, and symptoms may subside or not be noticeable. But if the urine stream has been reduced to a trickle, if strain is necessary to start the stream, or if there are frequent urges to urinate, especially at night, treatment is probably necessary.

Besides watchful waiting, where patient and physician monitor prostate conditions, four other BPH treatment options are available:

Another common prostate disorder, prostatitis, is caused by bacterial infections. Unlike BPH, prostatitis occurs mostly in younger men. It is usually treated with antibiotics.


Publication No. (FDA) 97-1220

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