Men with localized prostate cancer (PCa) treated with radical prostatectomy (RP) survive no longer than those undergoing observation, according to study results from PIVOT (Prostate Cancer Intervention versus Observation Trial) published in the New England Journal of Medicine.

For the trial, investigators randomly assigned 364 patients to have RP and 367 to undergo observation. During 19.5 years of follow-up, 223 RP patients (61.3%) and 245 observation patients (66.8%) died from any cause; 27 RP patients (7.4%) and 42 observation patients (11.4%) died from PCa. The between-group differences were not statistically significant. 

“This study confirms that aggressive treatment usually is not necessary,” co-author Gerald L. Andriole, MD, director of Washington University’s Division of Urologic Surgery, said in a news release issued by his university. “We hope the findings will steer doctors away from recommending surgery or radiation to their patients with nonaggressive early-stage prostate cancer and patients away from thinking it’s necessary.”

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“Our results demonstrate that for the majority of men with localized prostate cancer, selecting observation for their treatment choice can help them live a similar length of life, avoid death from prostate cancer and prevent harms from surgical treatment,” lead investigator Timothy J. Wilt, MD, MPH, of the Minneapolis Veterans Affairs Health Care System, said in the same release. “Physicians can use information from our study to confidently recommend observation as the preferred treatment option for men with early prostate cancer.”

The researchers noted that observation, PSA monitoring, and biopsy-based active surveillance are underused. They suggested raising the PSA and biopsy thresholds for intervention.  

Lower all-cause mortality was found for men with intermediate-risk PCa treated with RP (59.7% vs 74.2%), but not for those with low-risk or high-risk disease.

“It would be a disservice to dismiss surgery as a viable option for patients with intermediate-risk prostate cancer,” Dr Andriole said. “For these patients, and for some men with high-risk prostate cancer, surgery is often beneficial, as are other treatments such as radiation.”

PIVOT also showed that adverse events requiring treatment, such as urinary incontinence and erectile dysfunction were significantly more common with surgery than observation (17.3% vs 4.4% and 14.6% vs 5.4%, respectively) through 10 years. RP patients also experienced significantly more disease- or treatment-related limitations in activities of daily living through 2 years.

Treatment for disease progression was far less common after RP than observation (33.5% vs 59.7%), but most progression in this cohort involved asymptomatic disease, local progression, or biochemical recurrence.

The current findings generally confirm and extend the PIVOT results at 10 years of follow up (N Engl J Med 2012; 367: 203-13). During the original trial, conducted during the early era of PSA testing 1994 to 2002, 731 men (mean age, 67; median PSA, 7.8 ng/mL) with non-metastatic, node-negative stage 1 to 2 PCa of any grade were randomly assigned to RP or observation (i.e., palliative therapy or chemotherapy for symptomatic or metastatic progression). 

The investigators emphasized that their findings also generally agree with results from the SPCG-4 (Scandinavian Prostate Cancer Group Study Number 4) trial, conducted before the PSA testing era, and ProtecT (Prostate Testing for Cancer and Treatment), the later era of PSA testing. They suggest mortality differences may be due, in part, to differences in PCa detection and treatment approaches, including medical advancements.

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Wilt TJ, Jones KM, Barry MJ, et al. Follow-up of Prostatectomy versus Observation for Early Prostate Cancer. N Engl J Med 2017;377:132-42. doi: 10.1056/NEJMoa1615869

Surgery for early prostate cancer may not save lives. Washington University in St. Louis; July 12, 2017 (press release)