NCCN Prostate Cancer Guideline: "Ahead of Its Time," Says Panel Chair

Nick Mulcahy

March 16, 2010

Dr. James Mohler (Courtesy of NCCN)

March 16, 2010 (Hollywood, Florida) — The updated clinical practice guideline for prostate cancer from the National Comprehensive Cancer Network (NCCN) is "ahead of its time" and the "best recommendation" among the currently available organizational guidelines, said James Mohler, MD, the chair of the NCCN panel responsible for the document.

It's also the "first cancer-treatment panel to recommend not treating cancer," said Dr. Mohler here at the NCCN 15th Annual Conference, referring to the guideline's directive to initially treat many prostate cancers with active surveillance only.

However, Dr. Mohler, who is from the Roswell Park Cancer Center in Buffalo, New York, also hinted that it might be difficult to get patients to go along with guideline's new recommendation on active surveillance.

It's tough to get American men to have equipoise about this.

"It's tough to get American men to have equipoise about this," he told the NCCN audience.

Active surveillance is now the one and only recommended treatment strategy for men with very-low-risk and low-risk prostate cancer, according to the NCCN guideline. Full details on the updated guideline were reported by Medscape Oncology when they were first released in January.

The very-low-risk and low-risk categories account for about 40% of prostate cancers, Dr. Mohler told Medscape Oncology.

Getting men to accept active surveillance is one challenge, and keeping them on it is another, he reported.

At the 3 North American centers with the most experience using active surveillance, about one third of men cited "anxiety" as the reason for dropping out of surveillance and moving on to definitive treatment, noted Dr. Mohler during his presentation.

Dr. Mohler acknowledged that it is unclear "what the progression criteria should be to warrant treatment" in men on active surveillance.

We need more data to allow more physicians . . . and more men to feel comfortable.

He also urged meeting attendees to help enroll patients in the landmark Surveillance Therapy Against Radical Treatment (START) trial, the first-ever North American phase 3 trial comparing active surveillance with treatment.

"We need more data to allow more physicians . . . to feel comfortable about offering active surveillance to their patients and more men to [feel comfortable about continuing] on active surveillance," Dr. Mohler told Medscape Oncology, referring to the need for START to succeed in its enrollment of participants.

Ahead of It's Time, Defined

In addition to being the first cancer-treatment panel to recommend not treating all cancers, the NCCN guideline has been ahead of the curve for some time, suggested Dr. Mohler.

"The NCCN guideline committee introduced active surveillance as an option for clinically advanced prostate cancer in the 2007 guideline, life expectancy estimation in the 2008 guideline, and made an assessment of the threat posed by prostate cancer to one's estimated life expectancy the required beginning of any treatment discussion in the 2009 guideline," he said.

"Now, in the 2010 guideline, we recommend active surveillance as the only recommended treatment for men with low-risk prostate cancer and a life expectancy of less than 10 years, and for men with very-low-risk prostate cancer and a life expectancy of less than 20 years," he explained.

Very-low-risk prostate cancer is a new designation for the NCCN, and includes men with a stage T1a tumor; a Gleason score of 6 or below; a prostate-specific antigen (PSA) level below 10 ng/mL; fewer than 3 positive biopsy cores (with <50% cancer in each); and a PSA density below 0.15 ng/mL per g.

The timing of the new recommendations makes it appear that the NCCN is reacting to recent prostate cancer screening trial results in the United States and Europe, said Dr. Mohler. Two huge studies published last year showed that PSA screening had either no or little effect on the death rate from prostate cancer (N Engl J Med. 2009;360:1310-1319 and 1320-1328).

In a way, one could say we are responding to the [New England Journal of Medicine] papers.

"In a way, one could say we are responding to the [New England Journal of Medicine] papers [published] in March 2009. But we laid the groundwork for this long before," he said.

Before the meeting, NCCN staff told Medscape Oncology that they anticipated a lively discussion between Dr. Mohler and audience members at the meeting's prostate cancer presentation.

But as it turned out, there was little chance for any discussion; Dr. Mohler's was the last presentation of the day and it was long, leaving time for only 1 question.

Input from Blogosphere

The NCCN's new prostate cancer guideline has critics.

Life expectancy should not be an issue when evaluating men for active surveillance, said Peter Carroll, MD, MPH, chair of urology at the University of California, San Francisco.

"All low-risk men should discuss active surveillance with their doctors, including young men who are likely to live another 40 years," he told Medscape Oncology when the NCCN first introduced the new prostate cancer guideline.

In his Medscape blog, Controversies in Urology, Gerald Chodak, MD, from the Midwest Prostate and Urology Health Center in Chicago, Illinois, says that the active surveillance guidance has a basic flaw: "The problem is that level I evidence is not the basis for these recommendations."

But, as Dr. Mohler pointed out during his presentation, there is "a lack of sound data to support most [prostate cancer] recommendations."

"We have precious little level I data clearly supporting treatment either. We know most men diagnosed with [carcinoma of the prostate] by PSA are not destined to die of their prostate cancer. The NCCN statement is a step in the right direction. Remember that [active surveillance] always carries the option for treatment; it is not irrevocable (like treatment)," one urologist commented on Dr. Chodak's blog, echoing Dr. Mohler's assertions.

Another urologist agreed with Dr. Mohler's view that it is difficult to get men to embrace active surveillance, writing that: "This is a dilemma I discuss with every patient both before and after a (positive) prostate biopsy. Almost all of my patients have elected therapy for [carcinoma of the prostate] 'after the genie is out of the bottle'."

Dr. Mohler is chief medical officer of AndroBiosys, a prostate cancer treatment and testing company.

National Comprehensive Cancer Network (NCCN) 15th Annual Conference. Presented March 13, 2010.

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