Medical Device Daily National Editor

NEW YORK – With device-focused treatment options coming to the fore in recent years, Piper Jaffray (Minneapolis) rolled out a panel of four prominent practitioners in the prostate cancer space during the 19th annual edition of the company's healthcare investment conference here this week.

Senior research Analyst Thom Gunderson — who regularly graces independent lists of top analysts in the sector — did some stage-setting by noting that cancer "has become a more interesting investment forum over the past two years."

The Wednesday afternoon panel drew what appeared to be the largest audience of any session held in the Grand Ballroom of the Pierre Hotel during the two-day conference program. The panelists reflected a wide range of treatment approaches, from robotic prostatectomy to various forms of radiation treatments, including the implanting of brachytherapy seeds.

Nearly an hour's worth of sometimes-fevered discussion built off an opening scenario set by Gunderson and fellow Piper analyst Mark Arnold for the four physician panelists:

Here's a 63-year-old man who has just been diagnosed with prostate cancer – how do you treat him?

Ash Tewari, MD, director of robotic prostatectomy and prostate cancer-urologic outcomes at the Brady Urology Institute (New York), advocated "streamlining what we are trying to achieve" as physicians. The first goal, he said, "is to remove the cancer in the way that works best for the patient."

Irving Kaplan, ME, assistant professor at the Joint Center for Radiation Oncology at Harvard Medical School (Boston) and a radiation oncologist at Beth Israel Deaconess Medical Center (Boston), said, "I always tell the patient that there is no definitive right answer," although the longer quality-of-life studies that have been conducted to date "demonstrate that any form of radiation therapy is superior to radical prostatectomy."

Referring to one of the most common clinical approaches, he said, "I absolutely don't endorse watchful waiting."

Jeffrey Forman, MD, medical director for seven Michigan clinics in the nationwide 21st Century Oncology chain, said his response would be built on the organization's breadth and depth of clinical experience. "We would get multiple opinions from the different types of physicians in our practice."

Forman said one of the shortcomings of clinical services in the prostate cancer space is the lack of long-term data on the many new treatment regimens and technologies that have evolved over the past several years.

"Unlike women and breast cancer," he said, "studies for men and prostate cancer have been done in extremely limited ways. That's a problem for the average patient, and especially for the intelligent patient – in looking on the Internet, they don't get definitive answers."

Noting that clinicians "don't have the data to say what the best treatment is," Forman said that the treatments used for prostate cancer 20 years ago "weren't at all like those today."

Since the treatments that are gaining favor are so relatively new, he said, "we don't have data that's older, say, than 10 years."

And, in fact, even data of that length isn't especially useful. "The technology that has evolved today is totally different from what we did even five to 10 years ago," Forman said.

Further to the question of how he would treat the hypothetical patient, he said that 21^st Century Oncology treats about 800 patients a day nationwide, with many different types of treatment approaches.

"We don't say 'This is the way to treat it' in any singular form," Forman said.

Frank Critz, MD, founder and medical director of Radiotherapy Clinics of Georgia (RCOG; Atlanta), has personally treated more than 8,000 men over a 25-year career, using a treatment method developed at RCOG called ProstRcision, which means excision of both normal and cancerous prostate cells.

"What I would tell [this patient]," Critz said, "is forget about the treatment form – what you want to focus on is outcomes."

He said he would go to RCOG's database of 25,000 treated patients, "and give him statistics that would apply regarding urinary incontinence, sexual activity, etc."

Critz said he encourages patients to seek out multiple opinions. "Go to other doctors, ask about their outcomes, and use those doctors if their outcomes look good to you."

As for himself, he said, "You have to know your own data – I can't over-emphasize that."

Kaplan noted that any discussion of new treatment technologies must include the factor of reimbursement for that treatment – and that is keyed to outcomes. "Payers want to see data before they approve new technologies for reimbursement."

He noted that the costs of treatment "may force some patients to different treatments." A new CyberKnife system from Accuray (Sunnyvale, California) runs in the $4 million to $5 million range and then is reflected in a significant charge to the patient.

Kaplan said his organization is "doing the trials, gathering the data for CyberKnife."

Demonstrating the give-and-take of panel members, Critz interjected: "I wouldn't recommend CyberKnife because of the lack of data."

Terwari, who is focused on robotic surgical treatments, said that, "for now, we see that patients who undergo prostectomies are likely to live longer and get sexual functions back, [and] 97% of them are free of urine leakage problems."

In Forman's view, the "broadly divergent" clinical literature on relatively new treatments "makes interpreting the data very complicated."

He said that "unless there is an amazing breakthrough, something showing that this is the best approach, over the next 10 years we're going to have many patients select radiation and just as many select surgery."

Forman noted how patients "want the latest, best model [of new technology]. After I did a CNN news item last year, we received 2,000 calls in 24 hours."

By way of reference, he said he treats 300 to 400 patients a year.

"New technology appears to be better," Forman said, "but we need the supporting data, [because] patients are more and more sophisticated."

Among the new technology he cited is imaging technology from Calypso Medical Technology (Seattle), featuring GPS "beacons" that are injected into tumors. "It's really cool technology," he said, "and very expensive."

Expensive or not, 21st Century Oncology bought not one, but two of the new 4-D localization systems, which serves as an illustrative point to the discussion about the growth of new technologies in the prostate cancer sector.