One of the most contentious debates in medicine centers on a walnut-sized organ in men known as the prostate gland.
An estimated 241,740 men will develop cancer of the prostate this year, and 28,170 will die of the disease.
Doctors routinely use the PSA test to screen for the cancer. But the test can't tell which tumors will cause a problem, leading many men to undergo unnecessary therapies that risk incontinence or impotence.
Some medical authorities argue the test does more harm than good. Others strongly counter that it saves lives.
The result is confusion. Patients struggle with conflicting advice or may receive the test without a chance to weigh the options.
Now, in hopes of bringing clarity to the controversy, an influential group of doctors and health plans in Buffalo have spent months trying to agree on a communitywide guideline.
"We examined the opposing views and looked at what we could use to get to a common place," said Dr. Richard Vienne, chief medical officer of Univera Healthcare.
The group reached consensus on what the guideline should say. But there isn't agreement yet on how the recommendations should be used.
"Some physicians are concerned that this is an insurance company-led effort, and that the health plans will use the guideline to deny coverage," said Dr. Raghu Ram, chief medical officer at HealthNow New York, parent company of BlueCross BlueShield of Western New York.
The PSA test received approval from the Food and Drug Administration for the diagnosis of cancer in 1994. Since then, the test -- which measures levels of a substance known as prostate-specific antigen in the blood -- has become a routine part of a man's visit to the doctor, and millions of patients get tested every year.
Advocates of the test note that, in the early 1980s, most men learned they suffered from prostate cancer when it had metastasized and was incurable.
Today, approximately 90 percent of all prostate cancers are diagnosed at an early stage, when curative therapies can work, and death rates from prostate cancer have significantly declined.
The problem is that, until recently, there wasn't much scientific evidence to show if the PSA test was responsible for decreasing the number of people dying from the disease.
In the last few years, one study by U.S. researchers found no difference in the likelihood of dying of prostate cancer between patients who received PSA tests and those that didn't, although the study wasn't a true comparison between screened and unscreened groups.
One other study in Europe released mixed results in March.
It found that, after an 11-year period, PSA tests decreased the risk of death from prostate cancer, but screening made no difference in overall death rates because most men died of causes other than their prostate tumors. To prevent one death from cancer, the researchers concluded, 1,055 men would need to be screened and 37 cancers would need to be detected.
Is the test really of no benefit? Is there a small benefit but with risks that should be discussed with patients? Is there a larger benefit that will appear as researchers watch patients for more years?
Medical organizations offer conflicting guidance.
>An emotional issue
The U.S. Preventive Services Task Force, which reviews scientific evidence for tests and procedures, has controversially recommended against PSA screening for men who do not have highly suspicious symptoms, maintaining that the test has no net benefit or the harms outweigh the benefits.
The American Cancer Society recommends that otherwise healthy men without higher risks of prostate cancer discuss PSA tests and its implications with their doctor, noting that research has not yet proven that potential benefits outweigh the harms of testing and treatment. Because prostate cancer often grows slowly, the organization says men with a life expectancy of less than 10 years should not get the test.
The American Urological Association says patients need to be informed of the risks and benefits of testing. The specialist group also recommends that discussions of options include active surveillance as a consideration, since many prostate cancers don't require treatment.
For urologists, PSA screening is an emotional issue. They see the patients who develop cancer and live with the fear of lawsuits for not ordering the test.
"Patients have to understand that the test is not perfect, and that it opens a pathway you may not want to go down. But from our perspective, we like the test," said Dr. David Lillie, a Kenmore urologist. "We see fewer patients dying than in the past, but it's also true that we don't see the vast number of patients who have the test and nothing happens."
The group in Buffalo settled on recommendations that focus on two themes: Doctors should not order the PSA test reflexively, and they should discuss the pros and cons of screening with patients. The key points:
*Before initiating screening, the implications of PSA testing should be discussed.
*Consideration could be given to early detection beginning at age 50.
*Special consideration should be given to screening for high-risk populations, including African-Americans and those with a family history of prostate cancer, beginning at age 40.
*A person's age and life expectancy should be used to guide early detection decision-making.
*Patients over age 75 should usually not be considered for PSA early detection.
"The recommendations are an acknowledgment that the PSA test is not ideal. It misses cancers. It over detects tumors that are not relevant. But it's all we have," said Dr. Thomas Foels, chief medical officer at Independent Health.
For Foels and others, the troublesome aspect of PSA testing is that it has become routine despite a lack of evidence that it is effective. Yet there is evidence of potential harm as a result of the choices men make after they get the test results.
The U.S. Preventive Services Task Force last year reported that up to 5 in 1,000 men will die within one month of prostate cancer surgery from operation complications and between 10 and 70 men will suffer serious harmful events, including strokes and heart attacks.
Between 200 and 300 of those thousand men who get radiation and surgery, the task force wrote, get urinary incontinence or erectile dysfunction.
"The guideline is about driving home the point that patients need to be engaged in the decision," said Vienne.
Ram said insurers plan to share information with physicians about how often they use the PSA test in comparison with colleagues in the community. He said there is no intention to adjust policies on coverage.
"You can't put a restriction on a screening test like this. That would be a radical change," he said. "It would also be quite challenging to tie payment to how the test is performed. There is no convenient way for us to know whether a doctor used informed decision-making with a patient."
Vienne said it's hoped the P2 Collaborative of Western New York, a nonprofit group devoted to health issues, will help disseminate the guideline, allaying any fears that the document involves only insurers.
Historically, doctors decided on treatment decisions without much input from patients. That's changing with a growing movement to encourage patients to play a larger role in managing their care.
Shared decision-making allows patients and physicians to make decisions together while taking into account scientific evidence and patients' preferences, said Dr. Mary McNaughton-Collins, medical director of the Foundation for Informed Medical Decision-Making in Boston, Mass.
"When it comes to the PSA test, doctors need to make sure patients get accurate, understandable and unbiased information about their options," she said.
Quick facts and numbers paint picture of disease
*Most frequently diagnosed cancer in men aside from skin cancer.
*Second-leading cause of cancer death in men behind lung cancer.
*Incidence rates significantly higher in African-Americans, 241 cases per 100,000 men versus whites, 149 cases per 100,000 men.
*Incidence rates and deaths in United States have decreased since 2000.
*Nearly two-thirds of cases diagnosed in men 65 and older.