Study: Many men with prostate cancer can avoid early surgery

Many men with prostate cancer do not need immediate treatment, especially if they have low PSA scores or low-risk tumors that are unlikely to grow and spread, according to a multicenter study that suggests such men who undergo radical prostatectomy fare no better than those undergoing observation.

The study, published in the New England Journal of Medicine (2012; 367:203-13), drew a fast response from the AUA, which pointed out that the study’s data show the benefit of surgery in high-risk patients.

The study compared prostate cancer surgery soon after diagnosis with observation in men with early-stage prostate tumors detected by PSA screening. Overall, most men did not benefit from surgery-it did not reduce the likelihood they would die from prostate cancer or other causes. But the findings indicate that surgery did reduce mortality in two groups of men: those with PSA levels >10.0 ng/mL and potentially those with higher-risk, more aggressive tumors.

The study, called the Prostate cancer Intervention Versus Observation Trial (PIVOT) and led by Timothy J. Wilt, MD, at the Minneapolis Veterans Administration Health Care System, involved 731 men with an average age of 67 years and tumors confined to the prostate. The men were randomly assigned to surgery or observation.

After up to 12 years of follow-up, nearly half of the men in the study had died: 47% of men who underwent prostatectomy and 50% of men assigned to the observation group. But surgery reduced prostate cancer deaths among men with PSA levels greater than 10.0 ng/mL. Of these men, 5.6% in the surgery group died, compared with 12.8% of those in the observation group.

Fewer deaths from prostate cancer also occurred among men treated with surgery who had high-risk prostate cancer, classified as a PSA level >20.0 ng/mL and a Gleason score of 8-10. In this subgroup, 9.1% of men who had surgery died, compared with 17.5% for observation.

“For most men with low-risk prostate cancer, there is no evidence they need immediate treatment,” said co-author Gerald Andriole, MD, of Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis. “But the data suggest that men with high PSA levels and those with more aggressive tumors likely benefit from early surgery, and these men should undergo treatment because their tumors are more likely to be lethal if left alone.”

In a statement that followed the release of the new PIVOT data, the AUA cautioned against applying the findings to all men with localized disease.

“These data corroborate additional models (such as those developed by CISNET investigators) suggesting potential overtreatment, and further reiterating belief that not all men require active treatment for their prostate cancers,” said AUA Health Policy Chair David F. Penson, MD. “However, the positive findings in the high-risk patients underscore a strong need for reliable, effective biomarkers that allow us to distinguish low-risk disease from high-risk disease so we can prescribe treatment accordingly. Until we are able to distinguish between indolent and aggressive disease, some men with low-risk prostate cancer will desire treatment; this is appropriate in the absence of a certainty that they will die with prostate cancer, not of prostate cancer.

“Given that the median follow-up in PIVOT was only 10 years and the real possibility that patients with low-grade prostate cancer and longer life expectancies may garner some benefit from surgical treatment with longer follow-up, younger, healthier patients with low-grade prostate cancer should still strongly consider surgical treatment for their disease.”