NIH Independent Panel Weighs in on Active Surveillance for Prostate Cancer

Ricki Lewis, PhD

December 08, 2011

December 8, 2011 (Bethesda, Maryland) — "Active surveillance has emerged as a viable option that should be offered to low-risk patients" with prostate cancer, a 14-member independent panel of the National Institutes of Health (NIH) concluded yesterday. Panelists stated that "strong consideration should be given to removing the anxiety-provoking term 'cancer' for this condition."

The NIH convened a State-of-the-Science Conference this week to assess evidence on the role of active surveillance in managing localized prostate cancer. Members heard experts address changes in the patient population over the past 30 years, protocols for active surveillance, and factors affecting patient choices in following up after a positive biopsy finding.

Panelists defined "active surveillance" as "a disease management strategy that delays curative treatment until it is warranted based on defined indicators of disease progression," which is reclassification based on biopsy.

A consensus definition of low risk that includes prostate-specific antigen (PSA) and Gleason score is emerging, said conference chairperson Patricia Ganz, MD, from the Jonsson Comprehensive Cancer Center at the University of California at Los Angeles. "Using the definition of low-risk as a PSA value less than 10 ng/mL and a Gleason score of 6 or less, we estimate more than 100,000 men diagnosed with prostate cancer each year in the US would be candidates for active monitoring," she said at a news conference. The report clearly distinguishes active surveillance from the older "watchful waiting," which treats symptoms as they arise but does not aim to cure.

Before PSA concentration began to be used as a biomarker for hyperplasia in 1987, prostate cancer was commonly detected with a digital rectal examination, which revealed palpable neoplasms likely to have already metastasized. PSA testing detected many more cancers and led to many more biopsies and treatments. However, the observation that cancer deaths did not increase suggested that a substantial percentage of cases are unlikely to progress. Still, about 90% of diagnosed men seek immediate "curative treatment," which was the inspiration for the NIH conference this week.

Paul F. Schellhammer, MD, a urologist at Eastern Virginia Medical School in Norfolk, summarized the conference goal when he spoke at the start of the conference about his experience as a patient who chose treatment. "This conference will address the education of the patient and family so that they are comfortable with a discussion and decision that some prostate cancers — yes, even though the word 'cancer' is spoken — may best be managed initially with a surveillance strategy rather than surgical or radiation or medicinal intervention."

Laurence Klotz, MD, from Sunnybrook Health Sciences Centre in Toronto, Ontario, Canada, added: "This conference is a culmination of a long struggle to gain acceptance for this approach."

Reasons for refusing active surveillance include fear of cancer progression, minimal presentation of available options in printed materials and in discussions with physicians, and emphasis on treatment modalities by their practitioners, according to several invited speakers as well as panel members.

"Studies have shown that physicians' recommendations are very powerful," said panelist Nananda Col, MD, MPH, from the University of New England in Portland, Maine.

Barry Kogan, MD, panel member from Albany Medical College, Albany, New York, added that "the word 'cancer' sets off an emotional response that encourages patients to choose a more active treatment regimen."

The common fear of cancer, combined with the favorable prognosis of low-risk prostate cancer, influenced the panel members to suggest exploring dropping the emotionally charged word. "Cancer development is a continuum, but how we name it and how we talk about it may influence treatment choices. We shouldn't downplay that it is part of the neoplastic spectrum, but it is not as threatening as a highly invasive cancer," said Dr. Ganz.

No one suggested a replacement term.

The consensus statement spells out the unanswered questions. First on the list is reaching consensus on the best candidates for active surveillance. Another major remaining concern is to identify the "optimal protocol" while allowing flexibility to tailor procedures to an individual's clinical situation and wishes. "Different study sites follow different protocols, from very frequent PSA testing to much less," said Dr. Ganz. Dr. Klotz noted that biopsy rate varies, too. "We don't know the benefits and harms of each strategy," Dr. Ganz concluded.

Other suggestions were identifying ways to help patients with decision-making, exploring further why patients opt for active surveillance or immediate treatment, and assessing short- and long-term outcomes of active surveillance vs immediate curative treatment.

The NIH panel concluded that "Due to the paucity of evidence about this important public health problem, all patients being considered for active surveillance should be offered participation in multicenter research studies."

In the meantime, the State-of-the-Science report has assessed an impressive if nonuniform body of information to guide further investigation into optimal clinical approaches to handling low-risk prostate cancer.

Concluded Dr. Ganz, "We now have an NIH-vetted document that describes active surveillance as a reasonable approach to the management of localized prostate cancer."

The NIH statement can be read in its entirety at the NIH Web site.

The National Cancer Institute, Centers for Disease Control and Prevention, and the Office of Medical Applications of Research convened the conference. The quoted panel members and experts have disclosed no relevant financial relationships.

NIH State-of-the-Science Conference: Role of Active Surveillance in the Management of Men With Localized Prostate Cancer. Presented on December 7, 2011.

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