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1. Radical prostatectomy for early, localized prostate cancer led to better overall survival compared to watchful waiting.
2. Radical prostatectomy had greatest mortality benefit for men under 65 and those with intermediate risk tumors.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Early, localized prostate cancer can be treated with radical prostatectomy to remove the prostate gland. The procedure, however, can lead to complications such as erectile dysfunction and urinary incontinence.
The Swedish SPCG-4 trial follows about 700 men randomized to either radical prostatectomy or “watchful waiting” for early prostate cancer. Follow-up studies from this trial have been published at 3-year intervals and this is the 18-year follow-up from the original trial. This 18-year follow-up found that, compared to watchful waiting, radical prostatectomy reduced overall mortality as well as prostate cancer mortality, especially in men under 65 and those with intermediate-risk tumors.
It should be noted that in this trial, the watchful waiting group received symptomatic rather than definitive treatment when local progression was detected. This distinguishes watchful waiting from what some call “active surveillance”, where definitive treatment (radical prostatectomy) is given when progression is detected. In effect, the watchful waiting group in this trial represents the natural history of prostate cancer.
This trial was initiated prior to the advent of widespread PSA screening. Since such screening is now commonplace, new questions arise regarding prostate cancer treatment that need to be addressed. For example, now that PSA screening enables tumors to be detected even earlier, should radical prostatectomy be performed immediately after diagnosis or only after some threshold of disease progression is reached? SPCG-4 shows that radical prostatectomy is beneficial, but it is not clear when the procedure should be performed to best balance surgical morbidity against therapeutic benefit.
Click to read the study, published today in NEJM
Relevant Reading: Radical prostatectomy versus watchful waiting in early prostate cancer; Radical prostatectomy versus observation for localized prostate cancer; Long-term quality-of-life outcomes after radical prostatectomy or watchful waiting: the Scandinavian Prostate Cancer Group-4 randomised trial
In-Depth [randomized controlled trial]: Almost 700 men in Sweden with localized prostate cancer were randomized to either radical prostatectomy or watchful waiting between 1989 and 1999. The mean PSA level at enrollment was about 13ng/mL.
In this 18-year follow-up, risk of death from any cause was lower in the radical prostatectomy group (RR: 0.71, P<0.001). The risk of death from prostate cancer (determined via chart review by an independent committee) was also lower in the radical prostatectomy group (RR: 0.56, P<0.001).
The greatest reductions in risk of prostate cancer death were found among men under 65 (RR: 0.45, P=0.002) and men with intermediate-risk tumors (RR: 0.38, P<0.001).
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