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1.  Radical Prostatectomy or Watchful Waiting in Early Prostate Cancer 
The New England journal of medicine  2014;370(10):932-942.
BACKGROUND
Radical prostatectomy reduces mortality among men with localized prostate cancer; however, important questions regarding long-term benefit remain.
METHODS
Between 1989 and 1999, we randomly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy and followed them through the end of 2012. The primary end points in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) were death from any cause, death from prostate cancer, and the risk of metastases. Secondary end points included the initiation of androgen-deprivation therapy.
RESULTS
During 23.2 years of follow-up, 200 of 347 men in the surgery group and 247 of the 348 men in the watchful-waiting group died. Of the deaths, 63 in the surgery group and 99 in the watchful-waiting group were due to prostate cancer; the relative risk was 0.56 (95% confidence interval [CI], 0.41 to 0.77; P = 0.001), and the absolute difference was 11.0 percentage points (95% CI, 4.5 to 17.5). The number needed to treat to prevent one death was 8. One man died after surgery in the radical-prostatectomy group. Androgen-deprivation therapy was used in fewer patients who underwent prostatectomy (a difference of 25.0 percentage points; 95% CI, 17.7 to 32.3). The benefit of surgery with respect to death from prostate cancer was largest in men younger than 65 years of age (relative risk, 0.45) and in those with intermediate-risk prostate cancer (relative risk, 0.38). However, radical pros-tatectomy was associated with a reduced risk of metastases among older men (relative risk, 0.68; P = 0.04).
CONCLUSIONS
Extended follow-up confirmed a substantial reduction in mortality after radical prostatectomy; the number needed to treat to prevent one death continued to decrease when the treatment was modified according to age at diagnosis and tumor risk. A large proportion of long-term survivors in the watchful-waiting group have not required any palliative treatment. (Funded by the Swedish Cancer Society and others.)
doi:10.1056/NEJMoa1311593
PMCID: PMC4118145  PMID: 24597866
2.  Testing a Multigene Signature of Prostate Cancer Death in the Swedish Watchful Waiting Cohort 
While prostate cancer is a leading cause of cancer death, most men die with and not from their disease, underscoring the urgency to distinguish potentially lethal from indolent prostate cancer. We tested the prognostic value of a previously identified multigene signature of prostate cancer progression to predict cancer-specific death. The Örebro Watchful Waiting Cohort included 172 men with localized prostate cancer of whom 40 died of prostate cancer. We quantified protein expression of the markers in tumor tissue by immunohistochemistry, and stratified the cohort by quintiles according to risk classification. We accounted for clinical parameters (age, Gleason, nuclear grade, tumor volume) using Cox regression, and calculated Receiver Operator Curves to compare discriminatory ability. The hazard ratio of prostate cancer death increased with increasing risk classification by the multigene model, with a 16-fold greater risk comparing highest versus lowest risk strata, and predicted outcome independent of clinical factors (p=0.002). The best discrimination came from combining information from the multigene markers and clinical data, which perfectly classified the lowest risk stratum where no one developed lethal disease; using the two lowest risk groups as referent, the hazard ratio (95% confidence interval) was 11.3 (4.0–32.8) for the highest risk group and difference in mortality at 15 years was 60% (50–70%). The combined model provided greater discriminatory ability (AUC 0.78) than the clinical model alone (AUC 0.71), p=0.04. Molecular tumor markers can add to clinical parameters to help distinguish lethal and indolent prostate cancer, and hold promise to guide treatment decisions.
doi:10.1158/1055-9965.EPI-08-0044
PMCID: PMC2536630  PMID: 18583469

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