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Radical prostatectomy versus watchful waiting in early prostate cancer
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Urology.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Urology.
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2005 (English)In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 352, no 19, 1977-1944 p.Article in journal (Refereed) Published
Abstract [en]


In 2002, we reported the initial results of a trial comparing radical prostatectomy with watchful waiting in the management of early prostate cancer. After three more years of follow-up, we report estimated 10-year results.


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). The 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), and for 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).


Radical prostatectomy reduces disease-specific mortality, overall mortality, and the risks of metastasis and local progression. The absolute reduction in the risk of death after 10 years is small, but the reductions in the risks of metastasis and local tumor progression are substantial.

Place, publisher, year, edition, pages
2005. Vol. 352, no 19, 1977-1944 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-92865DOI: 10.1056/NEJMoa043739PubMedID: 15888698OAI: oai:DiVA.org:uu-92865DiVA: diva2:166172
Available from: 2005-05-12 Created: 2005-05-12 Last updated: 2015-02-20Bibliographically approved
In thesis
1. Localized Prostate Cancer: Results From a Randomized Clinical Trial
Open this publication in new window or tab >>Localized Prostate Cancer: Results From a Randomized Clinical Trial
2005 (English)Doctoral thesis, comprehensive summary (Other academic)
Alternative title[sv]
Lokaliserad prostatacancer : Resultat från en randomiserad klinisk studie
Abstract [en]

The aims of the thesis were to

• explore whether radical prostatectomy is beneficial compared with watchful waiting in survival and disease progression

• find possible effect modifiers

• evaluate a protocol of multiple biopsies and investigate if men with previous benign prostate biopsies are a group at risk for later prostate cancer

• inquire into patients’ and clinicians’ experiences of randomization in order to find out what made this study possible to conduct, and thereby contribute to improve randomization in the future

The background material was a large randomized clinical trial, the Scandinavian Prostatic Cancer Group Study Number 4, or SPCG-4, which was open for inclusion from February 1989 through December 1999. It comprised 695 men in Sweden, Finland and Iceland who had localized prostate cancer and were randomized to either radical prostatectomy or watchful waiting.

After a mean follow-up time of 6.2 years the first analyses, according to intention-to-treat, showed that radical prostatectomy reduced disease specific mortality, risk of metastases and risk of local progression but did not statistically significantly reduce overall mortality.

The second analyses confirmed our earlier findings and furthermore, at ten years, radical prostatectomy also statistically significantly reduced overall mortality. Age appeared as an independent effect modifier that will be further investigated.

A total of 547 men, with a suspicion of prostate cancer that had undergone multiple biopsies, and whose biopsies had benign histology were later compared with the background population to evaluate whether they were a group at risk of developing prostate cancer. Within six years of follow-up, there was no increased risk of prostate cancer.

Patients as well as clinicians used individual strategies to cope with the situation. The randomizing clinician has to understand the patient’s strategy and his expectations in order to individualize the information accordingly.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2005. 45 p.
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 25
Surgery, prostate cancer, localized, randomized, biopsies, interviews, Kirurgi
National Category
urn:nbn:se:uu:diva-5737 (URN)91-554-6206-5 (ISBN)
Public defence
2005-05-13, Rudbecksalen, Rudbecklaboratoriet, Dag Hammarsköldsväg 20, Uppsala, 09:15
Available from: 2005-05-12 Created: 2005-05-12Bibliographically approved

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