Guidance Statement From ACP Nixes Routine PSA Testing

Roxanne Nelson

April 08, 2013

For most men, the benefits of screening with the prostate-specific antigen (PSA) test are outweighed by the harms, according to new recommendations from the American College of Physicians (ACP).

The guidelines note that physicians need to inform patients about the benefits and harms of prostate cancer screening, and screening decisions should be based on the individual's preferences, prostate cancer risk, general health, and life expectancy.

The recommendations also state that men between the ages of 50 and 69 should discuss the limited benefits and substantial harms of the prostate-specific antigen (PSA) test with their clinician before undergoing screening.

In addition, physicians should not screen patients unless the individual expresses a clear preference for screening following a discussion of benefits and harms. Men at an average risk for disease should not be screened if they are younger than 50 years or older than 69 years, nor should men with a life expectancy less than 10 to 15 years.

The new guidelines appear in the April 9 issue of Annals of Internal Medicine.

Only a Modest Benefit

While a small number of prostate cancers are serious and can cause death, the vast majority are slow growing and not lethal, commented Amir Qaseem, MD, PhD, Director, Clinical Policy, ACP, and first author of the paper. "There is a need to balance the small benefits from screening with harms such as the possibility of incontinence, erectile dysfunction, and other side effects that result from certain forms of aggressive treatment."

Dr. Qaseem pointed out that there are many guidelines on this topic, and there is also controversy over PSA testing. "Some guidelines are developed from randomized trials and others are based on expert opinions," he said in an interview. "We conducted a review and the current evidence shows that there is a modest mortality benefit with PSA, but that there are also substantial harms associated with testing."

The potential benefit of prostate cancer screening corresponds to preventing about 1 death for every 1000 men, he explained, after 11 years of follow-up.

He noted that in the average-risk patient, the benefits do not clearly outweigh the harms. "Therefore, it is up to the patient," Dr. Qaseem said. "The PSA can detect cancer, and there is a small benefit to testing. And some men prefer to be tested."

Prostate cancer affects about 1 in 6 men, but only about 3% will eventually succumb to the disease. "It also rarely causes death in men younger than 50 years," he added, "And most deaths occur in men older than 75 years."

Debate and Conflict Over Screening

The debate over routine PSA screening has been a hot topic during the past few years, and certainly reached a crescendo following the US Preventive Services Task Force (USPSTF) recommendations against it. Some experts have pointed out that during the last 2 decades, and concurrent with the dissemination of PSA screening, there has been a significant decline in prostate cancer-specific mortality in the United States (Lancet Oncol. 2008;9:445-452).

The American Cancer Society, however, has updated its guidelines and put more of an emphasis on informed decision-making than previously. Men should only be screened "after they receive information about the uncertainties, risks, and potential benefits associated with prostate cancer screening," the document states.

To add to the controversy, 2 large clinical trials produced conflicting results. Results from the large US Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial suggest that prostate cancer screening does not reduce deaths from the disease. But data from the European Randomized Study of Screening for Prostate Cancer (ERSPC) suggest that PSA screening reduces prostate cancer mortality by about 20%.

A Complex Issue

The current guidance statement from ACP was developed by assessing current prostate cancer screening guidelines. They selected 4 guidelines from the American College of Preventive Medicine, American Cancer Society, American Urological Association, and US Preventive Services Task Force. The AGREE II (Appraisal of Guidelines, Research and Evaluation in Europe) instrument was used to evaluate the guidelines.

The authors note that, based on the current guidelines that were used in the assessment, "making decisions about screening for prostate cancer is a complex issue."

  • The 2012 USPSTF guideline concluded that the harms of prostate cancer screening outweigh the benefits for most men and recommended against screening using the PSA test.

  • The ACPM, ACS, and AUA guidelines all recommend using a shared decision-making approach, but they differ as to the actual recommendations for making a shared decision.

  • All of the guidelines did acknowledge that the benefits must be weighed against the serious harms, such as a false-positive rate of 70% for PSA levels greater than 4.0 and the harms associated with treating cancer that would not have become clinically evident in the patient's lifetime.

Making Shared Decisions

In the shared decision-making approach, the ACP states that it is important to educate the patient on several points including the following:

  • Prostate cancer screening with the PSA test is controversial.

  • While screening with the PSA test can detect prostate cancer, for most men, the chances of harm from screening with the PSA test outweigh the chances of benefit.

  • Most men who choose not to do PSA testing will not be diagnosed with prostate cancer and will die of something else.

  • The PSA test often does not distinguish between serious cancer and nonserious cancer.

  • The PSA test is not "just a blood test." It is a test that can open the door to more testing and treatment that a man may not actually want and that may actually harm him.

  • Studies are ongoing, so clinicians can expect to learn more about the benefits and harms of screening, and these recommendations may change over time.

  • Men are also welcome to change their minds at any time by asking for screening that they have previously declined or discontinue screening that they have previously requested.

These recommendations apply only to average-risk men, but shared decision-making is important for high-risk men as well. The ACP authors write that men who are at higher risk should receive information about the uncertainties, risks, and potential benefits associated with prostate cancer screening beginning at age 45 years. Those who are at an appreciably higher risk should begin receiving this information at age 40 years.

"High-value care reflects care for which the benefits are likely to outweigh the harms and costs associated with delivering such care," the authors write, but "screening with the PSA test is low-value care."

"The value of screening for prostate cancer in most cases is low, given that the chances of harm with screening outweigh the chances of benefit for most men and that the direct and indirect costs associated with biopsy, repeated testing, aggressive therapy, patient anxiety, and missed work are significant," they conclude.

Financial support for the development of this guideline comes exclusively from the ACP operating budget.

Ann Intern Med. 2013;158.


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