BBI Contributing Editor

SAN FRANCISCO, California The annual gathering of the American Urological Association (AUA; Baltimore, Maryland), held here last month at the recently enlarged Moscone Convention Center, was well attended, with an estimated 10,000 physicians from around the world enjoying great weather and a wealth of information for their predominantly male patients. As usual, the key topics included male erectile dysfunction, with the newer agents Cialis and Levitra drawing significant interest. In addition, the treatment of benign prostatic hyperplasia, more commonly known by its acronym BPH, drew considerable attention. Laserscope's (San Jose, California) green light KTP laser and its photo-selective vaporization (PVP) of the prostate procedure is demonstrating excellent clinical benefits and rapidly capturing market share from the gold standard of BPH surgical intervention, transurethral resection of the prostate, or TURP.

Another important topic that perennially captures attention at any AUA meeting is the treatment of prostate cancer. According to the American Cancer Society (ACS; Atlanta, Georgia), prostate cancer is the most common type of cancer found in American men, other than skin cancer. The ACS estimates that there will be about 231,000 new cases of prostate cancer in the U.S. this year, resulting in about 30,000 deaths. Prostate cancer is the second-leading cause of cancer death in men, exceeded only by lung cancer.

In contrast to these grim statistics, the death rate for prostate cancer has been declining in recent years, as widespread use of the prostate-specific antigen (PSA) test has meant that the disease is being found and then treated earlier. In addition, surgical techniques and procedures have improved sufficiently to extend life. For many years, the mainstay therapies for prostate cancer were external beam radiation therapy and the surgical excision of the prostate gland (radical prostatectomy, or RP). In the mid-1990s, brachytherapy (radioactive seed implants) began to gain significant market acceptance and now has become a bulwark for the treatment of prostate cancer.

According to Millennium Research Group (MRG; Toronto, Ontario), there were about 175,000 prostate cancer interventions in the U.S. in 2003, with external beam radiation and brachytherapy each accounting for about 36% of total interventions, with RP at about 23% of the total. As in many other medical device arenas, minimally invasive techniques are making their mark in the field of prostate cancer. Laparoscopic RP (LRP) debuted in the early 1990s but several limitations, notably a restricted operating space and a limited degree of freedom to manipulate the laparoscopic instruments resulted in a situation that a speaker at this year's conference termed "operating with chopsticks." As a result, LRP has failed to become a mainstream intervention for prostate cancer surgery.

However, the introduction a few years ago of the Intuitive Surgical (Sunnyvale, California) da Vinci Surgical System, an "intuitive" computer-enhanced, laparoscopic surgical robot to the field of prostate cancer surgery has begun to make an enormous impact on the field. Initially, the uptake of this technology and the associated procedure, which is called the da Vinci radical prostatectomy (DVP), was sluggish. The reasons included the huge capital cost (about $1.1 million), the high cost of disposables (about $1,000 per procedure), the steep learning curve (about 25 cases for the surgeon to attain proficiency) and the usual caution by surgeons in changing their ways. This year's AUA meeting marked a dramatic upturn for DVP and it clearly was one of the highlights of the show. At Intuitive's continually packed exhibit booth at the convention center and at various sessions throughout the five-day meeting, urologists extolled the virtues of the DVP procedure.

At a press conference, David Wood, MD, professor of urology at the University of Michigan (Ann Arbor, Michigan), said that the da Vinci robot is "an attempt to bridge the gap between laparoscopic and open surgery," by providing the minimally invasiveness of laparoscopy with the relative ease of use of an open procedure. In a study at his institution, Wood said that while there is a learning curve and the DVP takes at least as long as an open RP, there are clear benefits to DVP, including significantly less blood loss, reduced or no hospital stay and a faster return to continence and sexual potency. Wood concluded his comments at the press conference by saying that "the future impact of robotic surgery will be enormous."

James Peabody, MD, a urologist at Henry Ford Hospital (Detroit, Michigan), is another big believer in the DVP. His hospital has performed more DVPs than any other U.S. institution and because its first da Vinci machine was so heavily used, a second unit was purchased recently. Interviewed at the Intuitive booth by The BBI Newsletter, Peabody stressed that DVP is a much better procedure in skilled hands than an open prostatectomy, mainly because it affords meaningful patient benefits. He also noted that DVP is rapidly becoming a patient-driven procedure, with men learning about this approach either on the Internet or through word of mouth.

Peabody's comments were echoed by another urologist, Vip Patel, MD, of St. Vincent's Hospital (Birmingham, Alabama), who told a substantial audience at the Intuitive booth that "patients are asking us for the robotic surgery, because they are attracted to its minimally-invasive approach."

DVP procedures are surging and now account for the largest number of Intuitive's procedures. According to a late-April report by Tom Gunderson, a medical device analyst at Piper Jaffray (Minneapolis, Minnesota), about 1,000 DVP procedures were performed with the da Vinci in 1Q04. By the fourth quarter, Gunderson projects that number to nearly triple to 2,700.

Another prostate cancer therapy enjoying booming growth is cryotherapy, which is dominated by Endocare (Irvine, California). According to MRG, cryoablation of the prostate accounted for a scant 4% share of the market in 2003, but it is forecasted to surge to an 11% share by 2007, which would represent the fastest-growing modality in the prostate cancer surgery space. Endocare's 1Q04 results bear testimony to the robust growth of cryotherapy, as the company showed a 37% jump in prostate cryotherapy procedures over the comparable 2003 period. That growth rate was in line with its procedure growth in 2003 over the 2002 performance and is all the more impressive considering the company has been ensnared with onerous accounting and legal problems since 4Q02.

Cryotherapy, or deep freezing to destroy malignant tissue, has been available for about a decade but had developed a poor reputation in the late 1990s because of erratic performance of the equipment, lack of reimbursement and the paucity of solid clinical data. Endocare has restored cryotherapy's credibility and, along with its lone competitor, Oncura (Plymouth Meeting, Pennsylvania), is experiencing increasing acceptance of the technology.

David Ellis, MD of Urology Associates of North Texas (Arlington, Texas), told BBI that there now is "overwhelming data that cryotherapy is good medicine." In fact, he indicated that his group practice, the largest in the U.S. with 36 urologists on board, has turned almost entirely to cryotherapy and radical prostatectomy in dealing with prostate cancer. The group has purchased a da Vinci system and now is actively performing DVP procedures.

"These two modalities are clearly the future of prostate cancer therapy," Ellis said, noting that patients are demanding the least-invasive method to treat this disease. He added: "I cannot imagine that knife surgery will be practiced 10 years from now."

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