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Radical Prostatectomy versus Watchful Waiting in Early Prostate Cancer

Created: 11/3/2007


Radical Prostatectomy versus Watchful Waiting in Early Prostate Cancer
Anna Bill-Axelson, Lars Holmberg, Mirja Ruutu, Michael Häggman, et al.
NEJM May , 2005;Vol.352: 19; 1977


  • Radical prostatectomy is becoming one of the most common major surgical procedures in many Western countries.
  • Approx 60,000 men undergo this operation per year in the USA
  • In 2002, we presented the results of a clinical trial in which radical prostatectomy was compared with watchful waiting in the management of early prostate cancer
  • Mean follow-up time was 6.2 years, a relatively short period in relation to the often long natural history of early prostate cancer
  • We found that, as compared with watchful waiting, radical prostatectomy reduced the risk of death due to prostate cancer by 50 percent and the risk of distant metastasis by 37 percent, but there was no statistically significant reduction in overall mortality
  • We now present a second analysis after an additional three years of follow-up


  • From October 1989 through February 1999,695 men with early prostate cancer (mean age, 64.7 years) were randomly assigned to radical prostatectomy (347 men) or watchful waiting (348 men)
  • Follow-up was complete through 2003, with blinded evaluation of the causes of death
  • The primary end point was death due to prostate cancer; the secondary end points were death from any cause, metastasis, and local progression


  • During a median of 8.2 years of follow-up, 83 men in the surgery group and 106 men in the watchful-waiting group died (P=0.04)
  • In 30 of the 347 men assigned to surgery (8.6 percent) and 50 of the 348 men assigned to watchful waiting (14.4 percent), death was due to prostate cancer
  • The difference in the cumulative incidence of death due to prostate cancer increased from 2.0 percentage points after 5 years to 5.3 percentage points after 10 years, for a relative risk of 0.56 (95 percent confidence interval, 0.36 to 0.88; P=0.01 by Gray's test)
  • For distant metastasis, the corresponding increase was from 1.7 to 10.2 percentage points, for a relative risk in the surgery group of 0.60 (95 percent confidence interval, 0.42 to 0.86; P=0.004 by Gray's test)
  • Local progression, the increase was from 19.1 to 25.1 percentage points, for a relative risk of 0.33 (95 percent confidence interval, 0.25 to 0.44; P<0.001 by Gray's test)


  • 10-year absolute differences in disease-specific and overall mortality were statistically significant,in favour of radical prostatectomy
  • The cumulative incidence of distant metastasis was lower in the surgery group than in the watchful-waiting group
  • Disease-specific mortality as a result of radical prostatectomy was greatest among, or even limited to, patients younger than 65 years
    • NB This result has limited interpretability because the numbers were small, and study was not powered to analyze subgroups
  • Substantial absolute differences between the two groups were found in terms of local progression (which can cause problems with the micturition, pain, and anxiety)
  • Also the need for hormonal treatment increased in frequency in the watchful-waiting group, as did the need for palliative radiation; both types of treatment were associated with side effects that influenced patients' quality of life and well-being
  • Thus, the more immediate, though stable, side effects associated with surgery (predominantly, impotence and incontinence) should be weighed against the increasing incidence of symptoms and use of treatments after the progression of disease in the watchful-waiting group
  • Our 10-year estimates show that radical prostatectomy is associated with a statistically significant reduction in all the end points
    • 44 % relative reduction in mortality due to prostate cancer
    • 26 % relative reduction in overall mortality
    • 40 % relative reduction in the risk of distant metastasis
    • 67 % relative reduction in local progression

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