Philipp Dahm, MD, MHSc, FACS; Scott Gilbert, MD, MS, FACS
What is the relative efficacy of radical prostatectomy compared with observation for mortality in men with localized prostate cancer?
Randomized controlled trial (Prostate Cancer Intervention versus Observation Trial [PIVOT]). ClinicalTrials.gov NCT00007644.
Blinded* (outcome assessors).
Median 10 years.
44 Department of Veterans Affairs and 8 National Cancer Institute sites in the USA.
731 men ≤ 75 years of age (mean age 67 y, median prostate-specific antigen [PSA] level 7.8 ng/mL) with histologically confirmed, clinically localized, prostate cancer (stage T1-T2NxM0 in the tumor-node-metastasis classification system of the American Joint Committee on Cancer) of any grade diagnosed in the previous 12 months; PSA level < 50 ng/mL; negative bone scan for metastatic disease; life expectancy ≥ 10 years; and medically fit for radical prostatectomy.
Radical prostatectomy (n = 364) or observation, with an offer of palliative therapy or chemotherapy for symptomatic or metastatic progression (n = 367).
Primary outcome was all-cause mortality. Secondary outcomes were prostate cancer mortality (definitely or probably due to prostate cancer or prostate cancer treatment) and bone metastases. 740 men, enrolled over 7 years with 8 years of follow-up, were required to detect a 25% relative reduction in all-cause mortality with 91% power (α = 0.05) assuming median survival of 10 years.
100% (intention-to-treat analysis).
Radical prostatectomy and observation did not differ for all-cause mortality or prostate cancer mortality (Table). Prespecified subgroup analyses showed that prostatectomy reduced all-cause mortality more than observation in patients with PSA levels > 10 ng/mL (relative risk reduction 23%, 95% CI 4 to 40) but not those with PSA levels ≤ 10 ng/mL (relative risk increase 2%, CI −17 to 24, P = 0.04 for interaction). The radical prostatectomy group had a lower risk for bone metastases (Table).
In men with localized prostate cancer, radical prostatectomy did not differ from observation for all-cause or prostate cancer mortality.
Radical prostatectomy (RP) vs observation (obs) for prostate cancer†
†NS = not significant; other abbreviations defined in Glossary. RRR, NNT, and CI calculated from control event rates and hazard ratios in article.
‡Mortality definitely or probably due to prostate cancer or prostate cancer treatment.
Philipp Dahm, Scott Gilbert. Radical prostatectomy and observation did not differ for mortality in localized prostate cancer. Ann Intern Med. 2012;157:JC4–5. doi: 10.7326/0003-4819-157-8-201210160-02005
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Published: Ann Intern Med. 2012;157(8):JC4-5.
Hematology/Oncology, Prostate Cancer.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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