Great article in the WSJ on the University of Gothenburg's findings on the value of PSA to be more sensitive that in screening for other types of common cancers, such as breast and colon cancer. The facts are: 1) PSA is the most precise and sensitive of all tumor markers. 2) Prostate cancer is the most common cancer in men. 3) Prostate cancer is the second most common cancer in men. 4) If detected early, it's curable. The conclusion of the Gothenburg research: PSA screening and treatment can reduce the risk of death from prostate cancer by as much as 50%.
The real challenge for men is when it comes to choosing a treatment. There lies the real issue, in that among physician worldwide, there is no general consensus as to the optimal treatment. Instead, treatment recommendations are a bias of the specialty and the training of the treating physician: surgeons will recommend surgery, and radiation oncologist radiation. As the saying goes: "to hammer everything looks like a nail." Likewise, is the bias when it comes to treating prostate cancer. The latest craze is the Robotic prostatectomy! However, most recent evidence shows that Robotic prostatectomy has a higher risk of recurrence and no better clinical outcomes in the incidence of impotence and urinary incontinence. After all, it's still the same human hands directing the Robotic instruments.
Other unique characteristic about prostate cancer is that the standard treatments available come with a high risks of complications. Particularly in quality of life matters such as greater than 50% incidence of impotence and 10-20 % risk of urinary incontinence associated with surgical removal of the prostate. There are similar risks with radiation. Plus a high risk of developing a secondary cancer from the exposure to the radiation. These issues are so concerning to men, that they often elect on "watchful waiting" or "active surveillance" at the risk of progression of cancer and metastasis... another unique characteristic of prostate cancer. I certainly know of no malignancy where a patient would consider opting for no treatment at the risk of death.
For the past 7 years I have offered High Intensity Focused Ultrasound or HIFU to patients with localized prostate cancer. The technology has been approved in Europe and other countries since 1998, and currently is approved worldwide, except in the U.S. However, American urologist have embraced the procedure and travel with their patients to treat them in countries where it is approved. Another unique characteristic of prostate cancer: American urologist and their patients are willing to travel outside the U.S. in order to perform and receive this very advanced futuristic treatment. But this is not really unique, as Americans are familiar with seeking health care outside the U.S. while procedures and medications are pending FDA approval.
The principle advantage to HIFU is that there are less risk of impotence and incontinence: the two most dreaded potential complication feared by men. Clinical efficacy of HIFU in recent years has proven post treatment PSA (PSA Nadir) of the same range as surgical removal or radiation therapy. To the skeptics, the initial impression is that the whole thing is too good to be true. But it is that good, in efficacy of treatment, and less risk of complications. Otherwise, the FDA would not have allowed the clinical trials to progress from Phase I and II, to current phase III. Another interesting bit of information: None of the "standard" treatments available for treating prostate cancer was ever FDA approved, nor did any of them undergo any type of clinical trial. Instead they were "grand- fathered" as treatments that were used prior to more rigorous FDA regulation came into place.
The Gothenburg study will undoubtedly influence the application of PSA screening by both physician's use and patient's request. Unfortunate, this will lead to the potential risk of overtreatment and increase number of patients at risk of compromised quality of life. The American Cancer Society reports approximately 250,000 new cases of prostate cancer per year. Increase screening, as well longer living population, will lead to more patients diagnosed with prostate cancer. Potentially doubling the number of newly diagnosed patients per year. As well as creating a huge economic burden, if not a crisis in the cost of healthcare. The cost of treatments does vary, with radiation being the most costly. The cost of a HIFU treatment is significantly less than all standard treatments. In Addition, as an outpatient procedure, it allows the patient to return to work and other routine activities the day after treatment is a plus for patient convenience as well as lost of revenue and productivity.
The advantages of HIFU have been recognized by many health insurance companies in the U.S., to the point that many of them are pre-approving payment or reimbursing patient afterwards. Interestingly, Tricare for Life, the healthcare carrier for retired and active federal government employees has pre- approved payment for HIFU with the Sonoblade-500 device. Another challenging question: it is approved by the healthcare provider to federal government employees, but not FDA approved? Yet, I am confident that it will soon be available to Americans. But in the mean time, they can travel to almost anywhere in the world for HIFU treatments. HIFU Clinical trials are being performed in some of the most prestige's medical centers in the country. Including The Walter Reed hospital, where American soldiers and veterans receive unequaled best medical care.
How likely is HIFU to get FDA approval? Having personally performed over 2,000 cases, and trained hundreds of urologist from around the world, I am confident that HIFU will be approved. It just a matter of the time it takes to complete the trials. What impact will HIFU have as a treatment option for prostate cancer? Several Biomedical Wall Street analysts and industry newsletters predict a 91% compounded yearly growth over the next five years, with HIFU becoming the most common treatment for prostate cancer by 2015. I never imagined a four letter word would impact healthcare so positively and so powerfully. But it has happened before. I remember the huge incisions we made to remove tiny kidney stone, the ensuing pain and days of recovery. Sometimes resecting ribs and injuring adjacent tissue and whole organs. Then there came another four letter word: ESWL, (extracorporael shock wave lithotripsy) and no more opened surgery for kidney stones. ESWL was approved by the FDA in 1884. Interestingly, the science and technology of ESWL is the same as for HIFU. It's called piezoelectric energy. How big is HIFU as an available treatment for the most common cancer in men, and the second most common cause of death related to cancer versus the impact of ESWL? Kidney stone affects a small number of Americans, and patients typically don't die from kidney stones.
George M. Suarez, M.D. F.A.C.S.
Board Certified Urologist
305-595-0199
9195 Sunset Dr. Suite 110
Miami, Florida
www.hifumedicalexpert.com
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