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Study finds 'observation' as effective as surgery in early prostate cancer

thumbnail Tough decisions—A VA-led clinical trial has shed new light on the treatment options available to men with early-stage prostate cancer. There are some 240,000 new cases of the disease each year in the U.S.; about one in six men will get prostate cancer during his lifetime. (Photo: iStock)

A major federal study led by VA researchers found no difference in survival between men with early-stage prostate cancer who had their prostate surgically removed and those who were simply watched by their doctors, with treatment only as needed to address symptoms if they occurred.

The findings appeared July 19 in the New England Journal of Medicine.

"Our data show that observation provides equivalent length of life, with no difference in death from prostate cancer, and avoids the harms of early surgical treatment," said lead author Dr. Timothy Wilt. He called observation "a wise and good choice for many men."

Wilt is a physician-researcher with the Center for Chronic Disease Outcomes Research at the Minneapolis VA Healthcare System and a professor at the University of Minnesota.

The randomized trial involved 731 men and took place at 44 VA sites and eight academic medical centers. Known as the Prostate Cancer Intervention Versus Observation Trial, or PIVOT, the study was conducted and funded by VA's Cooperative Studies Program, with additional funding from the National Cancer Institute and the Agency for Healthcare Research and Quality.

One group of men in the study had a radical prostatectomy—surgical removal of the walnut-sized prostate. Surgery is generally performed in the belief it can lower the risk of prostate cancer spreading and causing death. Evidence has been lacking, though, as to whether the treatment is worth the risks, especially for men whose cancer was initially detected only on the basis of a blood test—the prostate specific antigen (PSA) test. In most cases, these tumors are not large enough to be felt during a doctor's exam and do not cause any symptoms.

The other men in the trial were in the "observation" group. With this approach, physicians generally do not provide immediate surgical or radiation therapy. Rather, they carefully follow men and provide treatments aimed at relieving symptoms, such as painful or difficult urination, if and when the cancer progresses and causes bothersome health problems.

The trial followed patients between 8 and 15 years. When Wilt's team analyzed the results, they found no difference in death rates between the two groups, either from any cause whatsoever or specifically from prostate cancer.

In terms of quality of life, the surgery group experienced nearly double the rate of erectile dysfunction—81 percent versus 44 percent—and roughly three times the rate of urinary incontinence—17 percent versus 6 percent. Bowel dysfunction was similar between the groups, 12 percent versus 11 percent.

Wilt said that while the results show observation is a good choice for many men, the equation may be different for those with higher-risk tumors. PIVOT found no difference in outcomes between the two groups for men with PSA values of 10 or less. But Wilt said there may be a survival benefit to surgery for men with PSA scores above 10, or other clinical results indicating more aggressive tumors.

Only about one in five men in PIVOT had tumors classified as high-risk. Wilt said this proportion is representative of U.S. men with an early-stage prostate cancer diagnosis based on PSA testing and follow-up biopsy. Prostate cancer is usually slow-growing, and most men with PSA-detected prostate cancer do not die from the disease or develop health problems related to it, even if it is not treated with surgery or radiation. Nonetheless, many men choose more aggressive treatment nonetheless. Says Wilt, "Concerns about cancer spread and death often fuel the desire on the part of both patients and providers for some type of early intervention."

Wilt's view was echoed by Durado Brooks, MD, MPH, director of prostate and colorectal cancers at the American Cancer Society. He said that when faced with a diagnosis of prostate cancer, most men choose to take some action. "This is partly because we haven't had any good long-term studies, but it's difficult to get past the fear of the word 'cancer,' he told Bloomberg News. "The [PIVOT] study shows the value in taking a step back and looking harder at watchful waiting or active surveillance."

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