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Therapeutics
Radical prostatectomy reduced death from prostate cancer but not all cause mortality

https://doi.org/10.1136/ebm.8.2.41

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    (2002) N Engl J Med 347, 781; Holmberg L, Bill-Axelson A, Helgesen F, et al.. A randomized trial comparing radical prostatectomy with watchful waiting in early prostate cancer.. ;. :. –9.
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    (2002) N Engl J Med 347, 790. Steineck G, Helgesen F, Adolfsson J, et al.. Quality of life after radical prostatectomy or watchful waiting.. ;. :. –6.
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 QUESTION: In men with early prostate cancer, is watchful waiting as effective as radical prostatectomy?

    Design

    Randomised (allocation concealed*), blinded {outcome assessors, data analysts, and monitoring committee}†,* controlled trial with median 6.2 years of follow up (Scandinavian Prostatic Cancer Group Study Number 4 [SPCG-4]).

    Setting

    14 centres in Sweden, Finland, and Iceland.

    Patients

    698 men <75 years of age with newly diagnosed prostate cancer and tumour stage T0d, T1, or T2. Patients with other cancers or signs of metastases were excluded. 695 men (mean age 65 y) had complete follow up.

    Intervention

    Patients were allocated to radical prostatectomy (n=347) or watchful waiting (n=348). Adjuvant treatment was not given. For local progression, prostatectomy group patients received orchidectomy or gonadotropin releasing hormone analogues and some watchful waiting group patients received transurethral resection.

    Main outcome measures

    Death from prostate cancer, distant metastases, local progression, and overall mortality. A subsequent follow up study assessed …

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    Footnotes

    • For correspondence: Dr A Bill-Axelson, University Hospital, Uppsala, Sweden. annabill-axelson{at}urology.uas.lul.se and Dr G Steineck, Karolinska Institutet, Stockholm, Sweden. gunnar.steineck{at}onkpat.ki.se

    • Source of funding: Swedish Cancer Society.

    • ↵*See glossary.

    • ↵†Information provided by author.