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Surgery failed to reduce mortality from PSA detected prostate cancer
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Compared with observation, radical prostatectomy did not significantly reduce mortality in patients diagnosed with early-stage prostate cancer after PSA testing came into practice, according to study results.
The US Preventive Services Task Force (USPSTF) recently recommended against routine PSA screening for healthy men — regardless of age — due to inadequate evidence of its effectiveness, as well its potential for overdiagnosis and overtreatment, according to background information in the study.
On July 16, an ASCO panel of experts issued a provisional clinical opinion that differs from the USPSTF recommendation. The ASCO opinion recommends physicians discuss the appropriateness of PSA screening for prostate cancer with men who have a life expectancy of more than 10 years.
The surgery vs. observation follow-up study furthers the debate regarding management approaches for patients with early-stage prostate cancer.
In the study, researchers evaluated 731 men with localized prostate cancer who were treated at 44 Department of Veterans Affairs centers and eight NCI sites.
Timothy J. Wilt, MD, MPH, core investigator for the Center for Chronic Disease Outcomes Research at the VA, and colleagues assigned patients to radical prostatectomy or observation from November 1994 to January 2002.
The mean age of the patients was 67 years.
During the 10-year median follow-up, 171 of 364 men (47%) assigned to radical prostatectomy died compared with 183 of 367 (49.9%) assigned to observation (HR=0.88; 95% CI, 0.71-1.08; absolute risk reduction [ARR]=2.9%), according to the study findings.
Twenty-one patients (5.8%) assigned to radical prostatectomy died of prostate cancer or treatment, compared with 31 patients (8.4%) in the observation group (HR=0.63; 95% CI, 0.36-1.09; ARR= 2.6%).
Among men with a PSA value of more than 10 ng/mL, surgery reduced all-cause mortality by 13.2% (HR=0.67; 95% CI, 0.48-0.94) compared with observation. Researchers did not observe a similar association among patients with a PSA value of less than 10 ng/mL (HR=1.03; 95% CI, 0.79-1.35).
As many as two-thirds of men who have received a diagnosis of prostate cancer have low PSA values or low-risk disease, but nearly 90% receive early intervention, which is typically surgery or radiotherapy, Wilt and colleagues said.
“Our findings support observation for men with localized prostate cancer, especially those who have a low PSA value and those who have low-risk disease,” Wilt and colleagues concluded.
Disclosure: The research was supported by grants from the Department of Veterans Affairs Cooperative Studies Program, the NCI, and the Agency for Healthcare Research and Quality.
Perspective
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Maha Hussain, MD, FACP, MD, FACP
There have been several recent critical developments with regard to prostate cancer. The US Preventive Services Task Force issued a recommendation against routine PSA screening for healthy men, regardless of age; an ASCO provisional clinical opinion recommended physicians discuss the appropriateness of PSA screening for prostate cancer with men who have a life expectancy of more than 10 years; and the results of a prospective randomized Department of Veterans Affairs-supported trial recently reported “among men with localized prostate cancer detected in the PSA testing era, radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up.”
It is important not to lose sight of the key issues. Prostate cancer remains the most common cancer diagnosis and a major cause of death among American men. PSA screening resulted in a stage migration with the potential advantage of having men diagnosed with clinically localized disease, which has a high chance of cure with primary local therapy. On the other hand, the clear downside has been the overdiagnosis of clinically insignificant disease, which leads to over treatment with all the associated physical and health care costs. Overtreatment, along with the results of the VA trial, clearly highlights the importance of patient selection and uniform definition of biologic risk to avoid a one-size-fits-all approach to detection or therapy of early-stage disease.
Moving forward, it is crucial that the medical community, regulatory agencies and other stakeholders carefully consider the risks, benefits and costs of new potential detection tests and/or treatments. In the spirit of evidence-based medicine, proper trials are a must to better define the role of interventions a priori and not after the fact. Research focused on how to identify high-risk disease must be supported, and standards of care for therapies or new interventions must be defined by high-level evidence, based on randomized prospective trials with adequate follow-up and clinically meaningful endpoints.
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