Medical Device Daily Contributing Writer

ANAHEIM – The annual gathering of the American Urological Association (AUA; Linthicum, Maryland), which concludes today, drew more than 10,000 physicians from around the world. Capturing significant attention at any meeting of the group is prostate cancer. According to the American Cancer Society (Atlanta), about 219,000 new cases of prostate cancer will be diagnosed in the U.S. this year. It is by far the most common cancer in men, nearly double the rate of lung cancer.

About one in six American men will receive a diagnosis of prostate cancer during his lifetime, usually after age 60. This cancer will cause an estimated 27,000 deaths this year in the U.S., making it the second leading cause of cancer death in men, exceeded only by lung cancer. Several key technologies and procedures form the foundation for treating prostate cancer, including various forms of radiation, such as external beam radiation therapy (EBRT) and brachytherapy, and the long-time and conservative "gold standard" — surgical excision of the prostate (radical prostatectomy, or RP). Radiation accounts for around 50% of the prostate cancer treatment market, with RP accounting for another 30% of the procedures.

Because it is usually a very slow-growing cancer, an oft-repeated comment in urology circles is that "more men will die with prostate cancer than from it." And as a result, many men, especially those with localized, early-stage disease, opt for "watchful waiting." Supporting watching waiting was an article titled "20-Year Outcomes Following Conservative Management of Clinically Localized Prostate Cancer" in the May 4, 2005, issue of the Journal of the American Medical Association. It concluded: "the annual mortality rate from prostate cancer appears to remain stable after 15 years from diagnosis, which does not support aggressive treatment for localized low-grade prostate cancer."

A new technology — at least relative to the very well established modalities RP and radiation — is cryoablation or "deep-freezing" to destroy malignant tissue. Cryo currently has about a 5% share of the U.S. market,divided between two fairly small companies: EndoCare (Irvine, California) and Galil Medical (Plymouth Meeting, Pennsylvania). The former, publicly-owned, has been working diligently over the past few years to rebuild the reputation of cryo, which was tarnished about a decade ago by over promotion and poor clinical results. Its efforts have paid tremendous dividends in recent years, however, with a 30% compounded annual growth rate in prostate cryo procedures 2002-2006. It reported revenue for the calendar year of about $28 million.

Galil is privately-owned and in December 2006 completed a $52 million financing from a highly-regarded group of U.S. venture capitalists. This financing permitted Galil to exit its former joint venture with Oncura (Plymouth Meeting, Pennsylvania) and to expand its sales, marketing, and clinical programs in both the U.S. and Europe. At the time of this financing, Galil reported annual cryotherapy revenue in excess of $20 million.

This year's AUA event featured a plethora of very positive clinical results on cryo. Perhaps the most important one was a randomized clinical trial of 244 men with localized prostate cancer that demonstrated cryoablation at least as effective as external beam radiation therapy when used to treat localized prostate cancer.

The trial, described by one urologist as "landmark," was the first North American randomized clinical trial comparing two definitive prostate cancer treatments in the past 25 years to enroll more than 100 patients. The head-to-head trial, spearheaded by Bryan Donnelly, MD, a urologist at the University of Calgary (Calgary, Alberta), also showed that after 36 months, only 6.6% of the cryoablation patients had positive biopsy findings compared to 26.3% of the patients who underwent EBRT.

Commenting on this study at an EndoCare sponsored analyst's meeting, Donnelly said, "This study demonstrates that cryoablation is equivalent to EBRT when used to treat localized prostate cancer. He added: "cryoablation is a treatment option that should be considered by all patients who are diagnosed with localized prostate cancer."

Other significant information reported at the AUA was the Cryo-On-Line Data (COLD) registry, the largest database of cryoablation patients ever compiled. It is a web-based data collection and management tool and is sponsored by an educational grant from EndoCare. This registry included the results from 1,198 patients retrospectively analyzed from data of 27 U.S. physicians with a median follow-up of 25 months. The cryoablation patients had a positive biopsy rate of 6.8%, an ASTRO biochemical failure rate of 22.9% after five years, an incontinence rate of 2.9% and a fistula rate of 0.04%.

At Endocare's analyst meeting, Stephen Scionti, MD, a urologist from Hilton Head, South Carolina, called the very low incontinence rates "phenomenal," adding that for the first time he sees that the urology community is beginning to focus on quality of life (QOL) issues for prostate cancer patients and not just cure rate.

"We can no longer ignore QOL," he said. "Our patients, who are being diagnosed at a younger age, not only want a cure for their prostate cancer but they want to have a quality life. In my opinion, cryoablation offers the best possibility for that outcome."

During the meeting, an important document called "Guideline for the Management of Clinically Localized Prostate Cancer: 2007 Update" was released, an update of similar guidelines issued in December 1995. It took 5 1/2 years to update the 1995 guidelines. The need for this update is simple — over the past decade, a dramatic improvement in the diagnosis and treatment of prostate cancer has occurred, but with no consensus emerging regarding optimal treatment for the most common type of prostate cancer — localized, early-stage disease with no lymph node or distant metastasis. This group accounts for over 90% of all prostate cancers.

One of the key goals of this effort is to enable men and their families to sort out the "bewildering array of information from scientific and lay sources [that] offer no clear-cut recommendations." Speaking at an AUA press conference, panel chairman Ian Thompson, MD, professor of surgery and chief of urology at the University of Texas Health Science Center (San Antonio), said that "there simply is no one best therapy for treating prostate cancer today." Today's "well-informed consumer," he said, "armed with web-based information" needs to consider several factors — such as quality of life, cure preferences, life expectancy, recommendations from family and friends — in deciding how to proceed.

Current therapy options included watchful waiting/active surveillance, brachytherapy, EBRT, hormonal therapy and radical prostatectomy. In addition, the panel cited several other modalities, such as high-intensity focused ultrasound, high-dose brachytherapy, combination therapies and cryotherapy. These were not recommended in the guidelines because of limited published experiences and short-term follow-up. The panel specifically noted that cryoablation would be discussed in a forthcoming AUA "best practices policy" statement, to be released later this year. Thompson noted that at the time of preparation of this guideline, "there was not enough evidence-based data." His conclusion: the field offers a "patchwork quilt of information on prostate cancer and much work is left to be done."

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