Early radical prostatectomy improves disease-specific but not overall survival

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Early radical prostatectomy improves disease-specific but not overall survival

J Fam Pract. 2003 January;52(1):12-31

By

David C. Cunningham, MD

Warren P. Newton, MD, MPH

BACKGROUND: Does radical prostatectomy for early prostate cancer improve survival? Radical prostatectomy is frequently used in treating early prostate cancer, but there is little evidence that the operation is efficacious. This randomized controlled trial compared radical prostatectomy with watchful waiting, in patients with early prostate cancer.
POPULATION STUDIED: Study subjects included 695 Swedish men with newly diagnosed prostate cancer. Inclusion criteria were age younger than 75 years, well or moderately well-differentiated disease as defined by World Health Organization criteria, no known metastatic disease, ability to consent to and undergo radical prostatectomy, and life expectancy of at least 10 years. The average age of the study subjects was 65 years; only 5% of patients had their cancers diagnosed through screening. Most patients (75%) had stage T2 disease, with cancer clinically apparent but confined to the prostate. No information was provided about comorbid illnesses or racial composition that could influence prognosis. These patients appeared similar to patients who might present to a US family practice with early, but not the earliest, disease. Thus, these results may not generalize to many patients discovered in screening programs. Caution should also be extended in applying these results to African American men or men with significant medical comorbidities.
STUDY DESIGN AND VALIDITY: This randomized, controlled, multicenter study used concealed treatment allocation assignment. Subjects were assigned to radical prostatectomy or watchful waiting. Traditional radical prostatectomy was performed without an emphasis on sparing potency. During regularly scheduled follow-up exams, PSA levels, bone scans, and chest x-rays were obtained. Orchiectomy or hormone therapy was recommended for prostatectomy patients with local progression, and transurethral resection for local progression in the watchful waiting group. A blinded independent committee analyzed data extracted from patient records and determined end points. Crossover between the groups after randomization was approximately 7%. Analysis was by intention to treat; relative hazards were estimated using Cox proportional-hazards models, controlling for age, tumor stage, Gleason score, and PSA level.
OUTCOMES MEASURED: Primary outcomes were death from prostate cancer and all-cause mortality. Secondary outcomes were rates of metastatic disease and local progression. A companion study assessed quality of life, but cost of treatment and patient satisfaction were not addressed.
RESULTS: Complete follow-up was achieved with a median duration of 6.2 years. Men in the radical prostatectomy group had lower prostate cancer mortality than patients in the watchful waiting group at 8 years (absolute risk difference [ARD]=6.6; 95% confidence interval [CI], 2.1–11.1; number needed to treat [NNT]=15). No significant difference was found in all-cause mortality between the groups. Rates of distant metastasis and local progression were significantly less for the prostatectomy group than for the watchful waiting group (ARD=13.9; 95% CI, 8.0–19.8; NNT=7; ARD=41.8; 95% CI, 35.2–48.4; NNT=2, respectively).

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Early radical prostatectomy improves disease-specific but not overall survival

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