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Evidence summaries

Radical Prostatectomy Versus Watchful Waiting for Newly Diagnosed Prostate Cancer

Radical prostatectomy (RP) appears to decrease the risk of cancer specific death in men aged < 65 years with newly diagnosed clinically detected prostate cancer compared to watchful waiting (WW). However, there is no evidence currently available from randomized controlled trials regarding the relative beneficial and adverse effects of RP and WW for patients with prostate cancers detected as a result of PSA screening. Level of evidence: "B"

The quality of evidence is downgraded by indirectness (differences in studied patients and patients currently diagnosed with prostate cancer).

Summary

A Cochrane review [Abstract] 1 assessed two RCTs involving a total of 837 patients with newly diagnosed prostate cancer. One trial (the VACURG trial, n = 142) was judged to have a high risk of bias and therefore did not provide reliable evidence. The second trial Scandinavian Prostate Cancer Group Study 4 (the SPCG-4, n = 695) was judged to have a low risk of bias.

Baseline characteristics of trial participants in the SPCG-4 were: < 75 years of age; T0d (later changed to T1b) 11.9%, T1c 11.7%, T2 76.1%; Gleason score 2 to 4 13.1%, 5 to 6 47.6%, 7 22.9%, 8 to 10 5.0% and unknown 11.4%.

In the SPCG-4 study mortality from prostate cancer at 12 years was 12.5% in the RP group versus 17.9% in the WW group (RR 0.65, 95% CI 0.45 to 0.94). A subgroup analysis according to age at diagnosis showed a risk difference of 11.2 % in cancer specific mortality for patients < 65 years (RR = 0.50, 95% CI 0.30 to 0.84) and 0.1 % for patients ≥ 65 years (RR = 0.87, 95% CI 0.51 to 1.49) for RP versus WW. In the VACURG trial the overall mortality at 15 years did not differ significantly between the RP and WW groups (HR = 0.9, 95% CI 0.56 to 1.43).

Updated data on the SPCG-4 study was published in NEJM 2. Cumulative prostate-cancer specific mortality at 15 years was significantly lower in the RP group than in the WW group (14.6% and 20.7%, respectively; RR 0.62, 95% CI 0.44 to 0.87). All-cause mortality at 15 years was also lower in the RP group (RR 0.75; 95% CI 0.61 to 0.92).

Clinical comment: The SPCG Study 4 was performed at a time when PSA testing was not routinely performed (only 5.2% had tumors that were detected using screening), and the results may not be applicable to screen-detected cancers.

    References

    • Hegarty J, Beirne PV, Walsh E, Comber H, Fitzgerald T, Wallace Kazer M. Radical prostatectomy versus watchful waiting for prostate cancer. Cochrane Database Syst Rev 2010 Nov 10;11:CD006590. [PubMed]
    • Bill-Axelson A, Holmberg L, Ruutu M et al. Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med 2011;364(18):1708-17. [PubMed]

Primary/Secondary Keywords