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| |  Cryosurgery Very Successful In Treating Prostate Cancer Recurrence IRVINE, CA -- January 6, 2000 -- Endocare, Inc., developer of targeted cryosurgery, a Medicare approved primary treatment for prostate cancer, announced the results of a clinical study published in the journal Urology indicating that the same treatment is also effective for patients whose cancer has recurred after undergoing radiation therapy. Each year, 30 percent of the 180,000 men diagnosed with prostate cancer undergo radiation therapy as a primary treatment, of which approximately 40 percent or nearly 22,000 men have recurrence of the disease. For these men, secondary treatment with cryosurgery can stop the disease's progression and improve long-term survival, according to the study in this month's issue of Urology. The study of 43 men who were unsuccessfully treated with radiation therapy for prostate cancer shows that nearly two years following treatment with cryosurgery, 97 percent of men were disease free, meaning they had a prostate specific antigen (PSA) score of less than 4.0 ng/mL. Of these patients, 60 percent had an undetectable PSA, or a score of less than 0.1 ng/mL. "This is a breakthrough for men who have been unsuccessfully treated with radiation therapy," said Dr. Aaron Katz, assistant professor of urology at Columbia Presbyterian Center of New York-Presbyterian Hospital. "Cryosurgery -- both as a primary treatment and as a salvage treatment for men with recurring prostate cancer -- can result in long-term cure rates and has very few complications. Also, unlike other procedures, cryosurgery can be performed on older men or those who may have pre-existing health problems." The Urology study offers great promise for men with recurring prostate cancer who are frustrated with their limited treatment options. Typically, men have chosen between salvage radical prostatectomy, a major surgical procedure that can only be performed by a handful of U.S. urologists, hormone therapy or watchful waiting. Salvage radical prostatectomy improves long-term survival by 56 percent according to published studies, but because of the procedure's complexity, complications such as rectal injury and incontinence are high and the surgery is only recommended for young, healthy patients. Fewer than 5 percent of patients are considered eligible for salvage prostatectomy due to cancer stage or concerns regarding the major surgery. Hormone therapy, or the extended use of androgen drugs, can delay disease progression in 68 percent of men, but is not a cancer removal method. Side effects of hormone therapy include hot flashes, osteoporosis, weight gain and lethargy. "While the diagnosis of prostate cancer comes as a shock to anyone, to learn of its recurrence is even more disheartening," said Paul Mikus, president and CEO of Endocare, Inc. "By demonstrating the efficacy of cryosurgery for men who have failed radiation, this study offers new hope for overcoming the disease. We are enthusiastic about the data and look forward to continued growth of targeted cryoablation -- both as a primary and secondary treatment for prostate cancer." Cryosurgery is a minimally invasive procedure that uses extreme cold temperatures to freeze and destroy cancerous cells in and around the prostate gland. Patients who undergo cryosurgery typically spend one night in the hospital and can return to daily activities within a week. An advanced form of cryosurgery developed by Endocare called targeted cryoablation was used in the Urology study. This procedure combines cryosurgery with ultrasound and temperature monitoring, enabling physicians to visualize the freezing process and thereby improve safety and efficacy. Prior to participating in the study, all 43 men -- whose age averaged 69 years -- were placed on hormone therapy for three months to reduce the size of the prostate gland. After cryosurgery treatment, a digital rectal exam (DRE) and prostate specific antigen (PSA) blood test were conducted every three months and the average follow up was 21.9 months. At 21.9 months, 97 percent of men had a PSA of 4.0 ng/mL or below. Reports of major complications following cryosurgery were few and only four men, or 9 percent, reported incontinence. Some men reported minor rectal pain or swelling following the procedure, but these symptoms disappeared within three months following treatment. Men who undergo targeted cryoablation as a primary or secondary treatment for prostate cancer are first treated with epidural anesthesia so they are awake and can talk to the physician, but feel no pain during the procedure. A thin catheter that circulates warm fluid is placed in the urethra to protect it from cold temperatures. Next, slender cryoprobes are inserted through small incisions into the prostate gland. Liquefied argon gas, which is contained within the cryoprobe tips, freezes and destroys the cancer and Some patients may experience mild soreness for two to three days following targeted cryoablation; however, this side effect is common among all surgical prostate cancer treatments. Long-term side effects of targeted cryoablation are similar to other therapies and may include impotence, bladder outlet obstruction, pelvic pain, chronic urgency and rectal injury. To date, more than 50 U.S. medical institutions offer targeted cryoablation.
Related Links: Endocare, Inc.
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