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Grant Details

Grant Number: 5R01CA108746-03 Interpret this number
Primary Investigator: Steineck, Gunnar
Organization: Karolinska Institute
Project Title: Prostatectomy Vs Watchful Waiting - a Randomized Trial.
Fiscal Year: 2007
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Abstract

DESCRIPTION (provided by applicant): The long-term objective is to improve the prerequisites for evidence-based management of patients with an early, localized prostate cancer. This requires integration of data about effects on both survival and quality of life after long-term follow-up. The proposed study builds on a clinical trial in Sweden and Finland initiated in1989. In that trial, altogether 695 men with newly diagnosed, clinically localized (TOd, T1-2), diagnosed through 1999, were randomized to radical prostatectomy (N=347) or watchful waiting (N=348). After a median follow-up of 6.4 years, radical prostatectomy reduced mortality due to prostate cancer by 50 percent whilst overall mortality was not statistically significantly reduced. Unexpectedly, radical prostatectomy did not deteriorate the self-assessed quality of life as compared with watchful waiting. Our specific aims during an additional 5 years of intense follow-up reaching a medium of almost 11 years are to study whether 1) the absolute and relative survival benefit from radical prostatectomy increases over time, 2) a significant reduction in overall mortality can be documented after long-term follow-up, 3) the survival time following establishment of metastatic disease is longer in patients treated with radical prostatectomy than in those left with no prior treatment, 4) PSA doubling time before establishment of metastatic diseases is shorter in patients who have undergone radical prostatectomy than in those managed by watchful waiting!, 5) on an average, radical prostatectomy improves sense of well-being, self-assessed quality of life and of meaningfulness as compared with watchful waiting, 6) the symptom burden of disease increases more rapidly over time among patients managed by watchful waiting, 7) quality of life is higher following radical prostatectomy due to more successful counseling by the managing doctor, 8) support from next-of-kin and relatives is, due to a higher awareness of the disease, better after radical prostatectomy than after watchful waiting, increasing quality of life, 9) unspecific symptoms are more worrisome to patients managed by watchful waiting than to those treated by radical prostatectomy. The research methods include firstly continued complete follow-up on PSA monitoring, recurrence, treatment, and cause of death among those deceased and, secondly, an ambitious assessment of quality of life chiefly by means of qualitative interviews and self-administered questionnaires. Long-term results from this unique trial may provide information highly relevant for the counseling and clinical management of large numbers of patients with an early prostate cancer diagnosed clinically or by means of PSA-testing.

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Publications

Radical prostatectomy or watchful waiting in early prostate cancer.
Authors: Bill-Axelson A, Holmberg L, Garmo H, Rider JR, Taari K, Busch C, Nordling S, Häggman M, Andersson SO, Spångberg A, Andrén O, Palmgren J, Steineck G, Adami HO, Johansson JE
Source: N Engl J Med, 2014 Mar 6;370(10), p. 932-42.
PMID: 24597866
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Individualized estimation of the benefit of radical prostatectomy from the Scandinavian Prostate Cancer Group randomized trial.
Authors: Vickers A, Bennette C, Steineck G, Adami HO, Johansson JE, Bill-Axelson A, Palmgren J, Garmo H, Holmberg L
Source: Eur Urol, 2012 Aug;62(2), p. 204-9.
EPub date: 2012 Apr 19.
PMID: 22541389
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Long-term quality-of-life outcomes after radical prostatectomy or watchful waiting: the Scandinavian Prostate Cancer Group-4 randomised trial.
Authors: Johansson E, Steineck G, Holmberg L, Johansson JE, Nyberg T, Ruutu M, Bill-Axelson A, SPCG-4 Investigators
Source: Lancet Oncol, 2011 Sep;12(9), p. 891-9.
EPub date: 2011 Aug 5.
PMID: 21821474
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Radical prostatectomy versus watchful waiting in early prostate cancer.
Authors: Bill-Axelson A, Holmberg L, Ruutu M, Garmo H, Stark JR, Busch C, Nordling S, Häggman M, Andersson SO, Bratell S, Spångberg A, Palmgren J, Steineck G, Adami HO, Johansson JE, SPCG-4 Investigators
Source: N Engl J Med, 2011 May 5;364(18), p. 1708-17.
PMID: 21542742
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Inguinal hernia after radical prostatectomy for prostate cancer: results from a randomized setting and a nonrandomized setting.
Authors: Stranne J, Johansson E, Nilsson A, Bill-Axelson A, Carlsson S, Holmberg L, Johansson JE, Nyberg T, Ruutu M, Wiklund NP, Steineck G
Source: Eur Urol, 2010 Nov;58(5), p. 719-26.
EPub date: 2010 Aug 11.
PMID: 20728265
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Development of a new method for monitoring prostate-specific antigen changes in men with localised prostate cancer: a comparison of observational cohorts.
Authors: Tilling K, Garmo H, Metcalfe C, Holmberg L, Hamdy FC, Neal DE, Adolfsson J, Martin RM, Davis M, Fall K, Lane JA, Adami HO, Bill-Axelson A, Johansson JE, Donovan JL
Source: Eur Urol, 2010 Mar;57(3), p. 446-52.
EPub date: 2009 Mar 13.
PMID: 19303695
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Time, symptom burden, androgen deprivation, and self-assessed quality of life after radical prostatectomy or watchful waiting: the Randomized Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) clinical trial.
Authors: Johansson E, Bill-Axelson A, Holmberg L, Onelöv E, Johansson JE, Steineck G, Scandinavian Prostate Cancer Group Study No 4
Source: Eur Urol, 2009 Feb;55(2), p. 422-30.
EPub date: 2008 Sep 2.
PMID: 18783877
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Radical prostatectomy versus watchful waiting in localized prostate cancer: the Scandinavian prostate cancer group-4 randomized trial.
Authors: Bill-Axelson A, Holmberg L, Filén F, Ruutu M, Garmo H, Busch C, Nordling S, Häggman M, Andersson SO, Bratell S, Spångberg A, Palmgren J, Adami HO, Johansson JE, Scandinavian Prostate Cancer Group Study Number 4
Source: J Natl Cancer Inst, 2008 Aug 20;100(16), p. 1144-54.
EPub date: 2008 Aug 11.
PMID: 18695132
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