So many men are confused about prostate cancer screening – and for good reason.

Some researchers say there is a real benefit to screening while others say that there may not be – or worse, that the testing can actually do more harm than good. If the man is screened and subsequently diagnosed with the disease, he faces an even tougher decision about whether or not to undergo treatment.

Organizations like the American Cancer Society (ACS; Atlanta) don't have all the answers either.

"In the absence of either a crystal ball or the kind of genomic knowledge that would allow us to say with complete confidence, 'you have this kind of tumor,' or 'you have that kind of tumor,' our knowledge is imperfect," Robert Smith, PhD, director of cancer screening for the ACS, told Medical Device Daily. "Men need to know that this is a test that may save your life, but it is also a test in which you may perceive that it saved your life when in fact you may not have needed treatment at all."

That is why the ACS' newly updated prostate cancer screening guidelines reaffirm the recommendation that men should discuss the uncertainties, risks and potential benefits of screening for prostate cancer before deciding whether to be tested.

The update is the first since 2001 and was done as part of the organization's regular guidelines update process, the ACS said. The new guidelines place a strong emphasis on informed, or shared, decision-making between doctors and patients.

Smith said that this emphasis on informed decision-making is not new – the previous guidelines also recommended it – but data suggests that these discussions aren't really taking place as often as they should. So the ACS is now placing an even stronger emphasis on this recommendation, he said, along with detailed guidelines to help men reconcile their own values and preferences.

"Men need to hear the facts and understand them before making a decision about testing," Smith said.

The guidelines say that asymptomatic men – or, healthy men – who have at least a 10-year life expectancy should have an opportunity to make an informed decision with their healthcare provider about screening for prostate cancer after receiving information about the uncertainties, risks, and potential benefits associated with screening.

Like the previous ACS recommendations, the new prostate cancer screening guidelines also say these discussions should begin earlier for men at higher risk of the disease.

Men at average risk should start getting this information at age 50. Men at higher risk, including African American men and men with a father or brother diagnosed with prostate cancer before age 65, should start hearing this information at age 45. Men with multiple family members diagnosed with prostate cancer before age 65 should start receiving this information by age 40.

"We do not have data to allow us to say with measurable confidence that screening saves lives," Smith said. "There are quite a lot of data that suggest that there is a reduction in mortality associated with screening, but there are also data suggesting that that reduction is not very large."

The new guidelines also include updated clinical recommendations regarding screening tests, intervals, and follow up of abnormal results for men who choose to be screened. The guidelines recommend annual screening for men whose PSA level is 2.5 ng/ml or higher, but state that screening intervals can be safely extended to every two years for men whose PSA is less than 2.5 ng/ml. The guidelines affirm that a PSA level of 4 ng/ml or higher remains a reasonable threshold to recommend referral for further evaluation or biopsy for men at average risk of developing prostate cancer; for PSA levels between 2.5 and 4 ng/ml, doctors should consider an individualized assessment that incorporates other risk factors for prostate cancer in the referral decision, the ACS notes.

In response to the new ACS guidelines, the American Urological Association (AUA; Baltimore) agreed with most of the points the ACS makes in the document, while taking issue with other parts of it.

Peter Carroll, MD, chair of the panel that developed clinical guidance about prostate cancer screening for the AUA last April, told MDD there are more similarities between the two organizations' guidelines than differences. For example, he said, the AUA strongly agrees with the idea of informed decision-making and believes that these discussions should be taking place in healthy men before a biopsy is done.

However, Carroll said, he was "puzzled" by the part of the new ACS guidelines that recommend what he calls "uniformed cut points" – PSA levels varying between 2.5 ng/ml and 4 ng/ml – for basing screening decisions. "My only issue with that is that PSA alone may not be the most accurate way to detect risk," Carroll said, noting that family history, age, ethnicity, and previous biopsy characteristics are also important factors in considering a man's individual risk for prostate cancer.

"In my opinion, informed decision-making [means] it's important to have the best estimates of that patient's individual risk . . . rather than a population-based single cut point," Carroll said.

If PSA alone is used, Carroll told MDD, doctors will end up doing a biopsy on some patients with relatively low risk of prostate cancer and not doing a biopsy on some patients with a high risk of developing the disease.

"The AUA feels there is no single PSA standard that applies to all men, nor should there be," AUA President Anton Bueschen, MD, said in a statement responding to the new ACS guidelines. "Part of informed consent is giving patients as much information about their personal risk as is available. Applying population-based cut points while ignoring other individual risk factors . . . may not give a patient the most optimal assessment of his risk, including the risk of his grade disease."

Although there are a lot of gray areas involved when talking about prostate cancer screening and treatment, Carroll said he believes that guidelines for prostate cancer screening should be updated more often – as frequently as once a year – because there is so much new information and tools coming out that allow doctors to be "a little clearer with patients."

Carroll said he believes that part of the problem in this country is that detection and treatment are intertwined. Patients should be counseled prior to having a biopsy done and told that even if cancer is detected, treatment may not necessarily be recommended. "Detection and treatment are too tightly linked and we have to unlink them," he said.

Amanda Pedersen, 229-471-4212;
amanda.pedersen@ahcmedia.com