PSA screening cuts deaths by 29% in large European trial

March 28, 2012

Two additional years of results from the European Randomized Study of Screening for Prostate Cancer (ERSPC) confirm original findings that screening significantly reduces death from prostate cancer.

Two additional years of results from the European Randomized Study of Screening for Prostate Cancer (ERSPC) confirm original findings that screening significantly reduces death from prostate cancer.

Published in the New England Journal of Medicine (2012; 366:981-90), the study extended the patient follow-up to an average of 11 years and found that a man who undergoes PSA testing will have his risk of dying from prostate cancer reduced by 29%.

The extended ERSPC data showing that 31% fewer men than previously indicated would need to be diagnosed with cancer to save one life is likely to heighten contention between urologists and the U.S. Preventive Services Task Force, which recently recommended that healthy men no longer receive PSA testing as part of routine cancer screening.

ERSPC, the world’s largest prostate cancer screening study, involved 182,160 men between the ages of 50 and 74 years at entry, with a predefined core age group of 162,388 men 55 to 69 years of age. The trial was conducted in eight European countries. Men who were randomly assigned to the screening group were offered PSA-based screening, whereas those in the control group were not offered screening. The primary outcome was mortality from prostate cancer.

After a median follow-up of 11 years in the core age group, the relative reduction in the risk of death from prostate cancer in the screening group was 21% (rate ratio: 0.79; 95% confidence interval [CI]: 0.68 to 0.91; p=.001) and 29% after adjustment for noncompliance. The absolute reduction in mortality in the screening group was 0.10 deaths per 1,000 person-years or 1.07 deaths per 1,000 men who underwent randomization.

The rate ratio for death from prostate cancer during follow-up years 10 and 11 was 0.62 (95% CI: 0.45 to 0.85; p=.003). To prevent one death from prostate cancer at 11 years of follow-up, 1,055 men would need to be invited for screening and 37 cancers would need to be detected. There was no significant between-group difference in all-cause mortality.

"This provides decision makers on screening policies with important new data on the effectiveness of PSA testing in preventing deaths," said co-author Fritz H. Schröder, MD, of Erasmus University Medical Center in Rotterdam, the Netherlands. "However, the ERSPC is also near to completing additional studies on quality of life and cost-effectiveness, and these must be assessed before making a decision about the appropriateness of a national prostate screening policy."

Compared with the U.S., individual PSA testing started late in most European countries, meaning that only a relatively small number of men taking part in the control arm of the ERSPC study had previously taken a PSA test, according to ERSPC, which makes the study fundamentally different from the U.S.-based Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial that had a high contamination rate in the control arm, with at least 44% of participants already PSA-tested prior to being randomized into the study. The PLCO study has been unable to demonstrate any difference in prostate cancer mortality between the two arms of the study.

ERSPC and PLCO were the two large studies used by the USPSTF to reach its recommendation against PSA screening. At the 2012 AUA/American Association of Clinical Urologists Joint Advocacy Conference, urologists had an opportunity to exchange opinions about the recommendation with task force Vice-Chair Michael LeFevre, MD, and points about the ERSPC study were raised on both sides. Many of the urologists felt that the ERSPC findings were already trending away from the USPSTF position and had the USPSTF waited for later findings, it wouldn’t have reached the conclusion it did.

"The follow-up data from the ERSPC demonstrates an improved survival advantage across all age groups screened for prostate cancer, especially those patients followed for more than 10 years," said AACU President Arthur E. Tarantino, MD. "One would hope that the USPSTF takes this updated information into consideration as they prepare to finalize their recommendation regarding the utility of the PSA blood test as a screening tool for early-stage prostate cancer. How else do we explain the nearly 40% decline in the prostate cancer death rate over the last 20 years without an increase in the incidence of the disease?"

In a statement from the Large Urology Group Practice Association, Deepak Kapoor, MD, said, “The ERSPC confirms what those caring for patients with prostate cancer have observed over the last two decades, that we are detecting cancer earlier and saving lives.

"The decision on how to screen and treat prostate cancer should be made by patients and their doctors, and no government agency should try and restrict men’s ability to control their own health care," said Dr. Kapoor, of Integrated Medical Professionals, PLLC.

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