Researchers say 2012 prostate cancer screening study needs to be reconsidered

May 10, 2016
by Gail Kalinoski, Contributing Reporter
Guidelines recommended four years ago in a landmark study by the U.S. Preventative Services Task Force on reducing routine prostate cancer screenings for men are being questioned by New York City-based researchers who say prostate specific antigen (PSA) testing should still be an important tool in cancer detection and prevention.

Researchers from New York-Presbyterian and Weill Cornell Medicine published a letter to the editor in the May 5 issue of New England Journal of Medicine claiming there were problems in the 2012 study’s methodology and that their research found the results of the U.S. Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial may have been misrepresented.

That study, as reported by HCB News in May 2012, led the task force to declare PSA screenings did more harm than good because of a “high false positive rate” which could result in risky biopsies and the “over-diagnosis” of prostate cancer.

While there was outcry from some doctors and groups like the American Urological Association, the findings apparently led several major organizations to recommend against PSA screenings based on the results of that $400 million study.

The New York-Presbyterian and Weill Cornell Medicine researchers carefully examined the PLCO study’s methodology and found that many of the men in the control group who received PSA testing were not included as tested in the study reports, according to a press release about the new research. Their research found about 90 percent of the men in the control group had received PSA testing, meaning that it was not useful to compare the control and intervention groups as part of the trial.

Dr. Jim C. Hu, MPH, director of the LeFrak Center for Robotic Surgery at New York-Presbyterian /Weill Cornell Medical Center and the Ronald Lynch Professor of Urologic Oncology at Weill Cornell Medicine, said the researchers expect their findings to “have a profound impact on the debate over the value of PSA screening.

“While there are risks of over-diagnosis and over-treatment associated with PSA testing, it can play an important role in preventing prostate cancer deaths as part of a personalized approach to cancer screening,” Hu said. “We’re going to have to reconsider this issue.”

In an interview with HemOnc Today, Hu said the PLCO study was “good, in that it led to thoughtful questions and increased awareness in limiting tests to those who would benefit the most – younger men with longer life expectancies.” But he noted the PLCO study findings led to recommendations against PSA screenings, and reasserted his recommendation that the guidelines now need to re-examined “given that the limitations of the study are more severe than originally recognized.”

Hu pointed to the findings of another major study on the impact of widespread PSA testing, the European Randomized Study of Screening for Prostate Cancer, that were contrary to the PLCO study. That study pointed to a substantial reduction in prostate cancer mortality over time.

“It was unclear why the European Randomized Trial of Prostate Cancer Screening demonstrated a 21 percent prostate cancer death reduction, while the PLCO did not demonstrate any survival benefit to PSA screening,” Hu said in the HemOnc Today article.

Hu and his colleagues, Dr. Jonathan E. Shoag, M.D., the lead author on the research article, and Dr. Sameer Mittal, M.D., both of New York-Presbyterian Hospital, will be discussing their research and PSA screening at the annual American Urological Association meeting in San Diego on Monday, May 9.