Men diagnosed with prostate cancer who underwent surgery for the disease didn't fare better in terms of mortality than men who were simply monitored by their doctors, according to a new study led by a Minneapolis researcher.
The findings, published Thursday, July 19, in the New England Journal of Medicine, renew a long-standing debate over treatment options for prostate cancer, a disease that's expected to be diagnosed in 242,000 American men this year.
But some surgeons challenged the study's findings.
The lifetime risk for a man to receive a prostate cancer diagnosis is about 16 percent, but the risk of dying from the disease is just 3 percent -- facts that suggest some men might do just fine without rushing into treatment. Another reason to be cautious about surgery, doctors say, is that the procedure brings a significant risk of incontinence and erectile dysfunction.
Dr. Timothy Wilt, a researcher at the VA Medical Center in Minneapolis, said the new results clearly show that an approach to prostate cancer called "observation" or "watchful waiting" makes sense in most cases.
"Patients and their providers should be reassured that more than 90 percent of men with prostate cancer detected by (screening) will not die from their prostate cancer if treated with observation," Wilt said. "Surgery is very unlikely to prevent a death from prostate cancer or to help them live longer, but it subjects patients to serious and frequent harms."
Some surgeons, however,
said the conclusions aren't supported by the data in the study.
Dr. Peter Sershon, a urologist who operates at United Hospital in St. Paul, said that prostate cancer has a wide range of behaviors and each patient has a unique set of circumstances that defy blanket statements like those generated by the new study. For that reason, Sershon called the study's conclusions "dangerous."
The problem is that doctors don't always know in advance which patients have aggressive cancers that will wind up being killers, he said. That makes it tough to recommend, for example, that a 52-year-old patient simply watch and wait to see how the cancer progresses.
"The real conclusion that they got was that older men with low-risk cancers can be observed for at least eight years," he said. "But we knew that -- that's not new information."
"What this doesn't help us with is managing men who otherwise would have 20-30 years of life expectancy," Sershon said.
The study randomly assigned 731 men with localized prostate cancer to surgery or observation and followed them for an average of 10 years. The effect of the two approaches in terms of all-cause mortality and prostate-cancer mortality was a statistical tie.
The study suggested that a subset of men with intermediate-risk or high-risk tumors might fare better in terms of all-cause mortality with surgical treatment; the same goes for men with a prostate-specific antigen (PSA) screening score above a certain level.
But the study also found that adverse events within 30 days of surgery occurred in 21.4 percent of men, including one death.
"Our findings support observation for men with localized prostate cancer, especially those who have a low PSA value and those who have low-risk disease," researchers wrote. "Up to two-thirds of men who have received a diagnosis of prostate cancer have a low PSA value or low-risk disease, but nearly 90 percent receive early intervention -- typically surgery or radiotherapy."
In an editorial also published Thursday in the medical journal, two doctors argued that the new study's conclusions are contradicted by the 44 percent reduction in prostate-cancer mortality between 1993 and 2009. Such a dramatic reduction, the doctors suggested, must have something to do with screening and surgical treatment for the disease.
More broadly, the editorial argued that results from the new study are weak because not enough patients participated in the research.
The critique generated a sharp response from Wilt, the researcher in Minneapolis. He said researchers had trouble enrolling more people because doctors wouldn't let their patients participate in a study where many didn't undergo surgery.
"They thought they knew that surgery worked," Wilt said.
About 78,000 prostate cancer surgeries were performed in the United States during 2010, including 1,371 in Minnesota, according to the Agency for Healthcare Research and Quality. The average charge for a surgery was $38,229.
In addition to controversy surrounding prostate cancer surgery, doctors for years have debated the merits of prostate cancer screening tests. This year, the U.S. Preventive Services Task Force said healthy men shouldn't get routine prostate cancer screenings, saying PSA blood tests do more harm than good.
Just as the task force's recommendation sparked debate, the new study on prostate cancer surgery won't close the argument over treatment options, predicted Dr. Pat Courneya, the medical director for Bloomington-based HealthPartners, an insurance company.
Courneya said he found the new study results convincing, but added that they run contrary to the "belief systems" of many doctors.
"There is a great deal of built-up belief about what prostate cancer screening and prostate cancer treatment can do, so it takes a long time for people to absorb this kind of evidence be confident about it," he said.
Badrinath Konety, director of the Institute for Prostate and Urologic Cancers at the University of Minnesota, said he thinks most urologists have some degree of comfort with observation for men with low-risk cancers.
But when these patients are relatively young, they often feel that have "too much to risk" in not getting treated, Konety said.
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