Radical Prostatectomy versus Observation for Localized Prostate Cancer

Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs (VA) Health Care System, and Section of General Medicine, University of Minnesota School of Medicine, Minneapolis, USA.
New England Journal of Medicine (Impact Factor: 55.87). 07/2012; 367(3):203-13. DOI: 10.1056/NEJMoa1113162
Source: PubMed


The effectiveness of surgery versus observation for men with localized prostate cancer detected by means of prostate-specific antigen (PSA) testing is not known.
From November 1994 through January 2002, we randomly assigned 731 men with localized prostate cancer (mean age, 67 years; median PSA value, 7.8 ng per milliliter) to radical prostatectomy or observation and followed them through January 2010. The primary outcome was all-cause mortality; the secondary outcome was prostate-cancer mortality.
During the median follow-up of 10.0 years, 171 of 364 men (47.0%) assigned to radical prostatectomy died, as compared with 183 of 367 (49.9%) assigned to observation (hazard ratio, 0.88; 95% confidence interval [CI], 0.71 to 1.08; P=0.22; absolute risk reduction, 2.9 percentage points). Among men assigned to radical prostatectomy, 21 (5.8%) died from prostate cancer or treatment, as compared with 31 men (8.4%) assigned to observation (hazard ratio, 0.63; 95% CI, 0.36 to 1.09; P=0.09; absolute risk reduction, 2.6 percentage points). The effect of treatment on all-cause and prostate-cancer mortality did not differ according to age, race, coexisting conditions, self-reported performance status, or histologic features of the tumor. Radical prostatectomy was associated with reduced all-cause mortality among men with a PSA value greater than 10 ng per milliliter (P=0.04 for interaction) and possibly among those with intermediate-risk or high-risk tumors (P=0.07 for interaction). Adverse events within 30 days after surgery occurred in 21.4% of men, including one death.
Among men with localized prostate cancer detected during the early era of PSA testing, radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up. Absolute differences were less than 3 percentage points. (Funded by the Department of Veterans Affairs Cooperative Studies Program and others; PIVOT ClinicalTrials.gov number, NCT00007644.).

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    • "High-risk disease is the most lethal form of localized CaP and is responsible for a large proportion of CaP-specific mortality [1]. Definitive therapy with either radical prostatectomy or radiation improves survival for patients with high-risk CaP [5] [6] [7] [8] [9] [10]. Based on this evidence, well-defined guidelines for treating high-risk disease have been developed by the National Comprehensive Cancer Network (NCCN) [4]. "
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    ABSTRACT: Objectives: Treating high-risk prostate cancer (CaP) with definitive therapy improves survival. We evaluated whether having health insurance reduces racial disparities in the use of definitive therapy for high-risk CaP. Materials and methods: The Surveillance, Epidemiology, and End Results Program was used to identify 70,006 men with localized high-risk CaP (prostate-specific antigen level > 20 ng/ml or Gleason score 8-10 or stage > cT3a) diagnosed from 2007 to 2010. We used multivariable logistic regression to analyze the 64,277 patients with complete data to determine the factors associated with receipt of definitive therapy. Results: Compared with white men, African American (AA) men were significantly less likely to receive definitive treatment (adjusted odds ratio [AOR] = 0.60; 95% CI: 0.56-0.64; P < 0.001) after adjusting for sociodemographics and known CaP prognostic factors. There was a significant interaction between race and insurance status (P interaction = 0.01) such that insurance coverage was associated with a reduction in racial disparity between AA and white patients regarding receipt of definitive therapy. Specifically, the AOR for definitive treatment for AA vs. white was 0.38 (95% CI: 0.27-0.54, P < 0.001) among uninsured men, whereas the AOR was 0.62 (95% CI: 0.57-0.66, P < 0.001) among insured men. Conclusions: AA men with high-risk CaP were significantly less likely to receive potentially life-saving definitive treatment when compared with white men. Having health insurance was associated with a reduction in this racial treatment disparity, suggesting that expansion of health insurance coverage may help reduce racial disparities in the management of aggressive cancers.
    Urologic Oncology 12/2014; 32(8):1285-1291. DOI:10.1016/j.urolonc.2014.04.014 · 2.77 Impact Factor
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    • "Consequently, radical treatment seems possible for a significant proportion of patients who actually need it. Different conclusions have been drawn by the Prostate Cancer Intervention Versus Observation Trial (PIVOT), which showed that RP did not significantly reduce PCa-specific or overall mortality after a mean follow-up of 10 yr [3]. In this study, between November 1994 and January 2002, 731 men with cT1–T2NxM0 PCa, PSA <50 ng/ml, and aged 75 yr were randomly assigned to RP or WW. "

    European Urology 09/2014; 66(3):596. DOI:10.1016/j.eururo.2014.06.031 · 13.94 Impact Factor
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    • "Recent evidence from large randomised controlled trials (RCTs) in prostate cancer has challenged the current diagnostic and treatment pathway of the disease [1] [2]. This is due to an unfavourable benefit/risk ratio. "
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    ABSTRACT: Introduction Focal therapy may reduce the toxicity of current radical treatments while maintaining the oncological benefit. Irreversible Electroporation (IRE) has been proposed to be tissue selective and so might have favourable characteristics compared to currently used prostate ablative technologies. The aim of this trial is to determine the adverse events, genito-urinary side effects and early histological outcomes of focal IRE in men with localised prostate cancer. Methods Single centre prospective development (stage 2a) study following the IDEAL recommendations for evaluating new surgical procedures. Twenty men who have MRI-visible disease localised in the anterior part of the prostate will be recruited. The sample size permits a precision estimate around key functional outcomes. Inclusion criteria include PSA </= 15ng/ml, Gleason score </= 4+3, stage T2N0M0 and absence of clinically significant disease outside the treatment area. Treatment delivery will be changed in an adaptive iterative manner so as to allow optimisation of the IRE protocol. After focal IRE, men will be followed during 12 months using validated patient reported outcome measures (IPSS, IIEF-15, UCLA-EPIC, EQ-5D, FACT-P, MAX-PC). Early disease control will be evaluated by mpMRI and targeted transperineal biopsy of the treated area at 6 months. Discussion The NEAT trial will assess the early functional and disease control outcome of focal IRE using an adaptive design. Our protocol can provide guidance for designing an adaptive trial to assess new surgical technologies in the challenging landscape of health technology assessment in prostate cancer treatment.
    Contemporary Clinical Trials 09/2014; 39(1). DOI:10.1016/j.cct.2014.07.006 · 1.94 Impact Factor
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