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´╗┐BACKGROUND: The benefit of radical prostatectomy in patients with early prostate cancer has been assessed in only one randomized trial. In 2005, we reported that radical prostatectomy improved prostate cancer survival compared with watchful waiting after a median of 8.2 years of follow-up. We now report results after 3 more years of follow-up.METHODS: From October 1, 1989, through February 28, 1999, 695 men with clinically localized prostate cancer were randomly assigned to radical prostatectomy (n = 347) or watchful waiting (n = 348). Follow-up was complete through December 31, 2006, with histopathologic review and blinded evaluation of causes of death. Relative risks (RRs) were estimated using the Cox proportional hazards model. Statistical tests were two-sided.RESULTS: During a median of 10.8 years of follow-up (range = 3 weeks to 17.2 years), 137 men in the surgery group and 156 in the watchful waiting group died (P = .09). For 47 of the 347 men (13.5%) who were randomly assigned to surgery and 68 of the 348 men (19.5%) who were not, death was due to prostate cancer. The difference in cumulative incidence of death due to prostate cancer remained stable after about 10 years of follow-up. At 12 years, 12.5% of the surgery group and 17.9% of the watchful waiting group had died of prostate cancer (difference = 5.4%, 95% confidence interval [CI] = 0.2 to 11.1%), for a relative risk of 0.65 (95% CI = 0.45 to 0.94; P = .03). The Louis Vuitton Outlet Store Online difference in cumulative incidence of distant metastases did not Louis Vuitton Handbags Canada increase beyond 10 years of follow-up. At 12 years, 19.3% of men in the surgery group and 26% of men in the watchful waiting group had been diagnosed with distant metastases (difference = 6.7%, 95% CI = 0.2 to 13.2%), for a relative risk of 0.65 (95% CI = 0.47 to 0.88; P = .006). Among men who underwent radical prostatectomy, those with extracapsular tumor growth had 14 times the risk of prostate cancer death as those without it (RR = 14.2, 95% CI = 3.3 to 61.8; P < .001).CONCLUSION: Radical prostatectomy reduces prostate cancer mortality and risk of metastases with little or no further increase in benefit 10 or more years after surgery.Comment inSPCG-4: a needed START to PIVOTal data to promote and protect evidence-based prostate cancer care. [J Natl Cancer Inst. 2008]SPCG-4: a needed START to PIVOTal data to promote and protect evidence-based prostate cancer care.Wilt TJ. J Natl Cancer Inst. 2008 Aug 20; 100(16):1123-5. Epub 2008 Aug 11.A challenge to contemporary management of prostate cancer. [Nat Clin Pract Urol. 2009]A challenge to contemporary management of prostate cancer.Albertsen PC. Nat Clin Pract Urol. 2009 Jan; 6(1):12-3. Epub 2008 Dec 9.Re: Prostatectomy versus watchful waiting in localized prostate cancer: the Scandinavian Prostate Cancer Group-4 randomized trial. [J Natl Cancer Inst. 2009]Re: Prostatectomy versus watchful waiting in localized prostate cancer: the Scandinavian Prostate Cancer Group-4 randomized trial.Schulz RJ, Kagan AR. J Natl Cancer Inst. 2009 Jan 21; 101(2):124. Epub 2009 Jan 13.Words of wisdom. Re: Radical prostatectomy versus watchful waiting in localized prostate cancer: the Scandinavian Prostate Cancer Group-4 randomized trial. [Eur Urol. 2009]Words of wisdom. Re: Radical prostatectomy versus watchful waiting in localized prostate cancer: the Scandinavian Prostate Cancer Group-4 randomized trial.Albertsen P. Eur Urol. 2009 Apr; 55(4):989-90.  


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