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| |  New Cryosurgery Technique 97% Effective In Prostate Cancer IRVINE, CA -- July 2, 1999 - In this month’s issue of the journal Urology, a comparative study of 163 prostate cancer patients treated with two different methods of cryosurgery shows that 97.6 percent of patients treated with a new, advanced cryoablation technique - called targeted cryosurgery -- were cancer-free after six months. Targeted cryosurgery is a minimally invasive one- to two-hour procedure that enables physicians to precisely freeze and destroy cancerous tissue in and around the prostate gland. One-year follow-up data on a group of 31 patients treated with targeted cryosurgery (presented at the World Endo-Urology Conference in December 1998) confirmed that 97 percent of patients had a negative biopsy 12 months after treatment, indicating that they were still cancer-free. Prostate cancer is the second most common cause of cancer-related deaths among men, exceeded only by lung cancer, yet the disease is curable if detected early enough. Several treatment options exist for prostate cancer, ranging from radiation therapy to prostate removal. The results of the Urology study, which was conducted by a team of physicians from the Prostate Center at Crittenton Hospital in Rochester, MI., demonstrate that advances in cryosurgery technology have significantly improved clinical outcomes. The study, led by Fred Lee, M.D., and Duke Bahn, M.D., compared standard cryosurgery using a five-probe system to targeted cryosurgery using six to eight cryoprobes in order to determine whether more probes would improve the rate of prostate cancer ablation, yet avoid increasing surgical and post-operative complications. The physicians used a unique temperature monitoring system with the six- to eight-cryoprobe device, the Cryocare Cryosurgical System manufactured by Endocare, Inc., in combination with trans-rectal ultrasound to precisely freeze and destroy cancerous tissue in and around the prostate gland. The targeted cryosurgery technique proved three and one-half times more likely to ablate the prostate than standard cryosurgery and produced fewer complications. A two-year follow-up study of these patients showed that 97.6 percent of those treated with the Cryocare System were free of disease compared to only 83.4 percent of those treated with standard cryosurgery, a statistically-significant difference. "Targeted cryosurgery is helping the treatment of prostate cancer make a great leap forward," said Dr. Fred Lee, Sr., a radiologist and prostate cancer survivor. "With ultrasound visualisation, temperature monitoring and more cryoprobes, we can be confident that the entire prostate is destroyed for a successful outcome, while ensuring that surrounding tissues are unaffected. "Additionally, by using liquefied argon gas instead of liquid nitrogen, we can begin or stop freezing instantaneously and achieve faster and colder freezing during targeted cryosurgery." In all, one out of every nine American men will develop prostate cancer at some time in life -- most after age 65. The high incidence of prostate cancer has led to increased awareness of the disease and improved diagnostic and treatment methods. Although 37,000 American men will die from prostate cancer this year, 60 percent of all prostate cancers are found while they are still confined to the prostate -- and the five-year relative survival rate for men with localised prostate cancer is 100 percent. Several considerations must be made when determining the most suitable treatment for prostate cancer: the progression of the disease; the risk of recurrence; treatment costs; side effects; and the overall impact on the patient's quality of life. If the cancer is in an early stage, growing slowly and not causing any symptoms, an approach called watchful waiting (monitoring tumour growth while deferring treatment) may be recommended -- particularly with elderly patients who may not be able to tolerate the health complications of treatment. Prostate cancer is most commonly treated by surgically removing the prostate and some surrounding tissue (radical prostatectomy). This procedure is highly effective, but it is also very invasive, requiring a hospital stay of several days and a recovery period of several months. Radical prostatectomy, which costs between $25,000 US and $30,000 US, leaves 23 percent of patients incontinent and 89 percent impotent. Radiation therapy, which uses external high-energy rays or permanent implantable radioactive seeds (brachytherapy) to destroy cancer cells, is a less-invasive treatment alternative. External beam radiation, which costs approximately $15,000 US, is a six- to eight-week treatment that can produce fatigue and bowel disorders. Brachytherapy, which costs on average $14,200 US, exposes the patient and his family to the risk of radiation and can cause significant rectal problems. Additionally, some areas of the prostate may be left untreated and radioactive seeds may migrate to other parts of the body after brachytherapy. While radical prostatectomy is the gold standard for treatment of prostate cancer, many men are considering less-invasive treatment options that involve faster recovery, less severe side effects and fewer complications. Targeted cryosurgery is a minimally invasive procedure that involves little blood loss and only one percent of patients report incontinence. Physicians have found that targeted cryosurgery is most effective for patients with cancer that is confined to the prostate gland. During targeted cryosurgery, a patient is first treated with epidural anesthesia; he is awake and can talk to the physician, but feels 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 a small incision into the prostate gland. Liquefied argon gas, which is contained within the cryoprobe tips, freezes the cancer and tissue that reaches - 40 degrees Celsius (- 40 degrees Fahrenheit) or less is destroyed. After approximately 10 minutes, the physician completes the first freeze cycle and then immediately administers another treatment to help ensure that all cancer cells are killed. The entire procedure lasts about one to two hours and the patient can return home that day or the next morning. In general, patients can resume a normal lifestyle immediately after the procedure but should avoid strenuous activity for a few weeks. Some patients may experience mild soreness for two to three days following targeted cryosurgery; however, this side effect is common among all surgical prostate cancer treatments. Long-term side effects of targeted cryosurgery are similar to other therapies and may include impotence, bladder outlet obstruction, pelvic pain, chronic urgency and rectal injury. Patients should be aware that impotence occurs in 80 to 90 percent of patients who undergo targeted cryosurgery, a rate similar to prostatectomy. This is due to the intentional freezing of tissue outside the prostate gland to kill cancer cells that may have already spread beyond the prostate capsule. Freezing tissue beyond the prostate capsule is an important decision that helps in curing the cancer by ablating viable prostate tissue that could become malignant. Although this process may damage the nerves that allow a man to get an erection, most urologists advise treating such tissue because if not, cancer cells may still remain.
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