PIVOT Fails To Show Prostatectomy Survival Benefit For Localised Prostate Cancer

Survival outcomes do not significantly differ for localised prostate cancer patients managed with surgery or observation

medwireNews: Surgery for localised prostate cancer does not improve all-cause survival compared with observation, report the PIVOT trial investigators after 19.5 years of follow-up.

After a median of 12.7 years, 61.3% of the 364 men randomly assigned to undergo radical prostatectomy had died, as had a comparable 66.8% of the 367 men who received only observation.

Similarly, prostate cancer-specific or treatment-related death was reported for 7.4% of the surgical arm and 11.4% of the observation arm, giving a nonsignificant difference between the groups, say Timothy Wilt, from the University of Minnesota School of Medicine in Minneapolis, USA, and co-workers.

The findings “show that long-term prostate-cancer mortality remains low among most men with localized prostate cancer who are treated with observation and that death from prostate cancer is very uncommon among men with low-risk and low-PSA [prostate-specific antigen] disease”, the authors write in The New England Journal of Medicine.

“Reducing over-treatment is needed”, they conclude.

Further analysis suggested that men with intermediate-risk disease – based on tumour stage, histological score and PSA level – may have derived a significant all-cause mortality benefit from surgery not seen in those with low- or high-risk disease, with an absolute difference between trial arms of 14.5 percentage points versus 0.7 and 2.3 percentage points, respectively.

“[A]lthough men with high-risk disease have a poor prognosis, surgery may not provide large benefits with respect to mortality”, the researchers comment. “Safer and more effective options are needed.”

And although surgery was associated with a significantly lower rate of treatment for disease progression than observation, with an absolute difference of 26.2 percentage points, the researchers say this was mainly accounted for by treatment for asymptomatic, local or biochemical progression. There was no difference in the need for treatment for regional or systemic progression between the surgery and observation arms for men with low- or high-risk disease but for intermediate-risk patients, treatment for systemic progression was halved with surgery (5.4 vs 11.7%).

In the 10 years after surgery, rates of urinary incontinence, and both erectile and sexual dysfunction, were higher than over the same period in the observation group, with greater disease-related or treatment-related limitations in activities of daily living for the first 2 years and poorer sexual function satisfaction for 5 years.

“Nonetheless, regardless of the initial treatment, we found few differences between the trial groups in long-term bother, physical discomfort, worry about health, overall health, or limitations in activities due to prostate cancer or treatment”, they summarise.


Wilt TJ, Jones KM, Barry MJ, et al. Follow-up of prostatectomy versus observation for early prostate cancer. N Engl J Med 2017; 377: 132–142, first published online 13 July. DOI: 10.1056/NEJMoa1615869

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