The American Urological Association (AUA)'s updated Prostate-Specific Antigen Best Practice
    Statement, first presented at the annual meeting of the AUA in April, has been published in the November issue
    of 2009 in the Journal of Urology.

    The statement includes the controversial guidance that the prostate-specific antigen (PSA) test should be offered to men starting at
    the age of 40 years — which one critic has said is not supported by "any convincing evidence."

    The update also reiterates the AUA's position that prostate cancer screening with PSA is a matter of individual choice.

    There is no single standard that applies to all men.

    "The single most important message of this statement is that prostate cancer testing is an individual decision that patients of any age
    should make in conjunction with their physicians and urologists. There is no single standard that applies to all men, nor should there
    be at this time," Peter Carroll, MD, said in a press statement in April.

    Dr. Carroll is chair of the panel that developed the statement and is from the University of California, San Francisco.

    Men should be informed about the "risks and benefits of prostate cancer screening before biopsy," notes the newly published
    statement, which acknowledges that there is "strong evidence" that prostate cancer screening leads to overdetection and
    overtreatment.

    No Single Threshold Value and Other Changes

    The 2009 statement abandons the AUA's former position that "a single threshold value of PSA" should prompt prostate biopsy.

    For primary care physicians, the fact that there is no longer a single value threshold complicates matters, said Richard Hoffman,
    MD, from the University of New Mexico School of Medicine in Albuquerque, who has studied patient–physician interaction
    surrounding the PSA test.

    "The AUA guidelines no longer recommend a PSA threshold for biopsy, which makes referral decisions much more complicated for
    primary care providers," Dr. Hoffman told Medscape Oncology.

    Although the PSA threshold is gone, the new statement recommends that more than 1 PSA be administered before moving on to
    biopsy — but does not recommend a timeframe for doing so.

    There is a lot of variability with PSA. It's worth repeating within 4 or 5 weeks.

    "There is a lot of variability with PSA. It's worth repeating within 4 or 5 weeks," statement coauthor, Peter C. Albertsen, MD, told
    Medscape Oncology about his personal approach. Clinicians should determine their own timeframe for repeating the test,
    suggested Dr. Albertsen, who is from the University of Connecticut Health Center in Framingham.

    The decision to proceed to biopsy should also take into account free and total PSA, patient age, PSA velocity, PSA density, family
    history, ethnicity, biopsy history, and comorbidities, write the statement coauthors.

    The new best-practice statement is the first update of this document in 10 years, said Dr. Albertsen.

    "What's changed in the last 10 years is that there much more PSA testing going on and more potential for overdiagnosis and
    overtreatment," he added.

    New papers have made the problems a lot more real and in our face.

    The twin problems of overdiagnosis and overtreatment, which were largely theoretical in the past, said Dr. Albertsen, have now
    been documented by the 2 major trials evaluating the effectiveness of PSA screening — the European Randomized Study of
    Screening for Prostate Cancer (ERSPC) and, in the United States, the Prostate, Lung, Colorectal, and Ovarian Cancer Screening
    Trial.

    "Results from these trials published in new papers have made the problems a lot more real and in our face," said Dr. Albertsen.

    "PSA does not work well by itself in predicting prostate cancer," acknowledged J. Brantley Thrasher, MD, who is not one of the
    statement coauthors. Dr. Thrasher, an AUA spokesperson, is from University of Kansas in Lawrence, and spoke to Medscape
    Oncology earlier in the year about the challenges of PSA-based prostate cancer screening.

    The new best-practice statement concludes that certain men diagnosed with prostate cancer should be offered the option of active
    surveillance "in lieu of active treatment."

    Dr. Thrasher suggested that active surveillance might not find rapid acceptance and widespread employment. "A complete cultural
    overhaul is needed to change the perception that all prostate cancer needs to be treated," he said.

    Baseline PSA at Age 40: Where is the Evidence?

    The most controversial part of the best-practice statement, which also includes guidance on the posttreatment monitoring of PSA
    values, is the assertion that the PSA test should be given starting at age 40. In its press statement, the AUA acknowledged that the
    guidance about the start age "directly contrasts recent recommendations issued by other major groups."

    When the AUA first announced that it was lowering the recommended age for a baseline PSA to 40 years, the chief medical officer of
    the American Cancer Society, Otis Brawley, MD, told WebMD that the move would likely lead to more screening and more
    overtreatment of men who will not benefit.

    Dr. Hoffman, from the University of New Mexico, concurred. "It seems a curious decision for the AUA to encourage more screening
    at an even earlier age — given that this strategy may lead to more overdiagnosis and overtreatment without any certain benefits," he
    said.

    Their recommendation to start screening at age 40 is not supported by any convincing evidence.

    "Their recommendation to start screening at age 40 is not supported by any convincing evidence," Dr. Hoffman added.

    The only randomized study that indicates that PSA-based prostate cancer screening provides a mortality benefit did not indicate a
    benefit in younger men, he explained, referring to the ERSPC, 1 of the 2 landmark prostate cancer screening trials currently
    underway.

    "The European screening trial published data only for men ages 55 to 69. Younger men (50 to 54) had no benefit from screening
    and actually had a few more deaths — but the results were not highlighted because the sample size was small," he said about the
    trial data to date (N Engl J Med. 2009;360:1320-1328).

    The best-practice statement authors say that the guidance to start at age 40 is supported by a number of concepts and data.

    The measurement of the PSA level is a "more specific test for cancer in younger men compared to older men because prostate
    enlargement is less likely to confound the interpretation of the estimated PSA value," the statement authors argue, citing an earlier
    study (N Engl J Med. 1996;335:304-310).

    Also, "infrequent testing of men in their 40s and after age 50 might reduce prostate cancer mortality and the cost of screening when
    compared to annual testing beginning at age 50," they hypothesize.

    Having a baseline at a younger age could also provide clinicians and patients with perspective and history about PSA velocity,
    suggest the statement authors. "Given the relationship between [PSA velocity] and death from prostate cancer decades later,
    establishing baseline PSA values against which to compare future PSA measurements after age 50 could help identify those men
    with life threatening prostate cancer at a time when cure is still possible," they write.

    Finally, the authors argue, "those men found to be at increased risk for prostate cancer, but who do not have it, may be offered
    chemoprevention."

    This latter idea, which refers to using finasteride, was recently endorsed by the authors of a recent "rethink" and criticism of prostate
    and breast cancer screening. The essay, which was widely covered by major media, was critical of PSA-based prostate cancer
    screening and the way it triggers volumes of unnecessary biopsies and treatments.

    Dr. Carroll reports a financial and/or other relationship with Ismar Medical and Ismar Healthcare. Dr. Albertsen reports a financial
    and/or other relationship with Blue Cross/Blue Shield, GlaxoSmithKline, the National Cancer Institute, Agency Health Care Quality,
    Aureon Corporation, Sanofi, and Ikonysis. Their coauthors report relationships with various pharmaceutical and healthcare
    companies, which are detailed in the paper.

    J Urol. 2009;182:2232-2241. Abstract

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