The Lynx Group

Observation as Good as Radical Surgery for Localized Prostate Cancer, Especially Low-Risk Cancer

September 2012, Vol 3, No 6

In this era of upwardly spiraling healthcare costs, the management of low-risk prostate cancer is changing. Although approximately two thirds of men with a diagnosis of prostate cancer have a low prostate-specific antigen (PSA) value or low-risk disease, approximately 90% of these men receive early intervention, with surgery or with radiation. Findings from a new study from the Minneapolis Veterans Affairs Health Care System suggest that localized prostate cancer, especially low-risk cancer, can be safely managed by observation alone.

Radical prostatectomy was not significantly better than observation in preventing death from any cause, including prostate-specific death, in men with localized prostate cancer that was detected by PSA, according to the large, randomized Prostate Cancer Intervention Versus Observation Trial (Wilt TJ, et al. N Engl J Med. 2012;367: 203-213).

“Our findings add to evidence supporting observation, and possibly active surveillance, for most men who receive a diagnosis of localized pros­tate cancer, especially those with a low PSA value or low-risk disease,” wrote the investigators.

Between November 1994 and Janu­ary 2002, 364 patients were assigned to radical prostatectomy and 367 to observation. All patients (aged ≤75 years) had histologically confirmed localized prostate cancer of any grade diagnosed within the previous year, PSA <50 ng/mL (median at baseline, 7.8 ng/mL), a negative bone scan, and a life expectancy of at least 10 years from randomization. All the men underwent a biopsy to confirm the PSA-based diagnosis. Men assigned to observation were offered palliative therapy or chemotherapy for disease progression.

Based on review of biopsy specimens, 48% of the patients had Gleason scores of ≥7 and 66% had intermediate- or high-risk cancers.

Over a 12-year period (median follow-up, 10 years), 47% of the men who were assigned to radical prostatectomy died versus 49.9% of those assigned to observation alone, for a nonsignificant absolute risk reduction of 2.9% for surgery. The rates of prostate-specific cancer death were 5.8% for surgery versus 8.4% for observation alone, a nonsignificant 2.6% absolute risk reduction favoring surgery.

The effect of radical prostatectomy did not differ by age, race, perfor­mance status, coexisting illness, or histologic features of the tumor. Radical prostatectomy appeared to be superior to observation in reducing death from any cause among men with a PSA value >10 ng/mL and in those with intermediate- or high-risk tumors.

“Our study was conducted in the early era of PSA testing. The current practices of performing repeated PSA testing, using a lower PSA threshold for biopsy, obtaining more tissue-biopsy cores, and performing a repeat biopsy…increase the detection of smaller volume indolent cancers,” the investigators wrote. These factors lead to overdiagnosis and overtreatment, they noted.

Among men with intermediate-risk (ie, PSA of 10.1-20 ng/mL; a Gleason score of 7; or a stage T2b tumor) or high-risk prostate cancer, surgery reduced all-cause mortality by 10.5% compared with observation; however, in patients with low-risk disease, observation was favored over surgery.

For prostate cancer–specific mortality, surgery had an advantage compared with observation in men with a PSA value >10 ng/mL at diagnosis and among men with high-risk prostate cancer. No advantage was found with surgery versus observation in men with a PSA value <10 ng/mL.

Perioperative complications in the first 30 days after surgery were re­ported in 21.4% of men who underwent a radical prostatectomy. At 2 years, urinary incontinence and erectile dysfunction rates were significantly higher with surgery than with observation.

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