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Same-day surgery programs should consider offering cryoablation procedures to treat prostate cancer, as the Health Care Financing Administration (HCFA) will cover the procedure in the outpatient setting beginning April 1. HCFA will cover cryoablation, also known as cryosurgery and cryotherapy, when radiation therapy has failed. "Those are ideal patients to receive the treatment," says Harry S. Clarke, MD, PhD, associate professor in the Department of Urology at Emory University Medical School in Atlanta. "We don’t have any other treatment to offer them."
Cryosurgery uses extremely cold temperatures to freeze and destroy cancer cells in the area of the prostate gland. Patients are released in 23 hours or less. "If the patient has a comorbidity, we have a one-night stay; if not, it’s a one-day stay," says Duke Bahn, MD, chairman of the department of radiology and director of the Prostate Center at Crittenton Hospital in Rochester, MI. Prostate cancer is the second leading cause of cancer-related death in men.
Radiation therapy is associated with a 50% to 80% failure rate, according to Bahn. "Cryotherapy is an emerging alternative that shows great promise," he says. According to a study conducted by Bahn that was presented at the 2000 meeting of the Fairfax, VA-based American Society of Therapeutic Radiology and Oncology, for men undergoing cryosurgery after radiation failed, 95% were biopsy-negative five years later if the cancer was still confined within the prostate and 50% when cancer was locally spread. Some reported minor rectal pain or swelling immediately after the surgery, but those effects disappeared within three months.
An advanced form of cryosurgery developed by Endocare in Irvine, CA, combines cryosurgery with ultrasound and temperature monitoring to improve safety and efficiency in the procedure. Currently, more than 25 facilities in the United States offer the targeted cryosurgery procedure (See patient handout — "Frequently asked questions about prostate cancer treatment and targeted cryosurgery" — in this issue. For more information, go to the Web site: www.endocare.com.)
Candidates for cryoablation therapy should have accurate cancer staging with a transrectal ultrasound and a prostate biopsy prior to the procedure, Bahn says. "Knowledge of the exact location and size of the tumor, and the status of nearby structures, such as neurovascular bundles and seminal vesicles, proves crucial to the success of the treatment."
The cryosurgical procedure is tailored to each patient based on gland volume, tumor size, and extent of the disease, he says. To achieve a high level of accuracy in staging, use state-of-the-art ultrasound equipment with color-Doppler capability, Bahn advises. Others disagree.
"Prostate cancer is multifocal, and the entire gland is treated [frozen] just as the entire gland is treated with radiation," Clarke says. "There is, therefore, no need to use special Doppler ultrasound."
Patients will need a bone scan and CT scan of the pelvis to rule out the possibility of distant metastases (cancer spread), Bahn says. Clarke, however, says bone scan or CT scan is not necessary if the prostate-specific antigen is less than 10 and the Gleason score is six or less.
Bahn recommends lymph node sampling in selected cases. "If distant metastasis or lymph node involvement is confirmed, the patient is not a candidate for cryosurgery," he says.
Extensive preoperative medication (androgen ablation therapy) is used to downsize the prostate volume and downstage the disease. Cryosurgery is performed under general or spinal anesthesia. A team approach is used for targeted cryosurgery with a radiologist and a urologist.
Bahn usually makes five to eight needle punctures in the perineum and, using ultrasound guidance, advances the needles to preselected locations in the prostate gland. "The needle tracks will be dilated for insertion of the cryoprobes used for the freezing," he says.
The placement of probes is extremely critical, Clarke says. "You are making sure the entire prostate gland is frozen without freezing the rectum and urinary sphincter."
Precise temperature monitoring during the procedure is accomplished with multiple thermocouples placed at strategic locations surrounding the gland. After placing a urethral warming device to protect the urethra, the freezing process begins. "We apply a minimum of two freezes [two freeze-and-thaw cycles] for effective tissue destruction," Bahn says. "The entire prostate, including the tumor, and surrounding tissue will be frozen." The patient is discharged the next morning with a Foley catheter in place for two to three weeks.
One point to keep is mind is that the procedure is highly operator-dependent, Bahn emphasizes. "It takes about 100 patients for a surgeon to be comfortable with it." His hospital offers a two-day training course in the procedure and offers "virtual" surgery on a phantom. Afterward, his program proctors physicians for up to five patients before they try the procedure solo.
Impotency is an expected side effect of this procedure, Bahn says. "It is due to the intentional freezing of tissue outside of the prostate gland to kill cancer cells that may have already spread beyond the prostate capsule." Bahn’s study showed only 15% of patients regained potency, defined as a firm erection enough for vaginal penetration, and an additional 23% claimed partial recovery. These numbers are essentially the same when compared to the radiation and radical surgery reports, Bahn says.1,2 "To make sure you cure the cancer, [impotency] is the only way."
Other complication rates are relatively low, Bahn says. The major complication recorded is a fistula, which is a connection between rectum and prostatic urethra, which occurred in 0.25% of Bahn’s patients. "All except one patient who experienced this complication had failed radiation therapy prior to having cryosurgery," he says.
Another complication reported in patient questionnaires is urinary incontinence, defined as use of pad, in 4.3% of patients who have had no prior treatments for prostate cancer. It was reported as 11% after radiation therapy1 and 31% after radical prostatectomy.2 "In our study, most patients used one pad for a few drops a day as a protective measure," Bahn says. In the radiation failure group, the incontinence rate was significant higher than in the virgin group, he reports. Other minor complications include outflow obstruction in 9%, pelvic pain in 11%, scrotal swelling in 17%, and penile numbness or tingling sensation in 14%. "These usually resolved within three months after the cryosurgery," Bahn reports.
Importantly, 96% of patients stated that they would choose cryosurgery again if it became necessary, he says. Advantages of cryosurgery include the fact that the procedure can be repeated if the first cryosurgery has failed and radiation therapy has failed, Bahn says. Radical surgery or seed implantation is still an option if the first cryosurgery fails, he reports. Also, cost is less than half of the traditional treatment, he says.
On the downside, there have been no long-term randomized multicenter studies, he says. Also, insurance companies don’t always cover this procedure, Bahn says. "They may label this procedure as investigational. However, the American Urological Association [in Baltimore] approved this procedure as one of the treatment options and not an investigational [one]." If patients and providers forcefully appeal, they might receive coverage, he advises.
[Editor’s note: For more on Medicare coverage of cryosurgery, go to the HCFA Web site: www.hcfa.gov. Click on "coverage policies" and then "decisions." Under "closed decisions," click on "Cryosurgical Salvage Therapy for Recurrent Prostate Cancer (CAG — 00064)."]
1. Jonler M, Messing E, Ritter MA. Sequelae of definitive radiation therapy for prostate cancer localized to the pelvis. Urology 1994; 44:876-882.
2. Fowler FJ, Barry MJ, Lu-Yao G. Patient reported complications and follow-up treatment after radical prostatectomy. Urology 1993; 42:622-629.
For more information on cryosurgery, contact:
• Duke Bahn, MD, Chairman of the Department of Radiology and Director, Prostate Center at Crittenton Hospital, 1101 W. University Drive, Rochester, MI 48307. Telephone: (248) 652-5611. Fax: (248) 652-5431.
• Harry S. Clarke, MD, PhD, Associate Professor, Department of Urology, Emory University Medical School, 1365 Clifton Road, Atlanta, GA 30322. Telephone: (404) 778-4015. Fax: (404) 778-4006.