Urology Specialties, Conditions, Treatments & Technology

Targeted Cryotherapy of the Prostate

The goal of cryotherapy is to eradicate prostate cancer by freezing the prostate gland.
Cryotherapy selection criteriaCryotherapy is an option for prostate cancer patients who want to avoid major surgery or the risks of “watchful waiting.” Cryotherapy can treat prostate cancer patients in the intermediate and high risk groups (stage T2c or above) as well as those who have failed previous radiation treatment.

Frequently Asked Questions About Prostate Cancer Treatment And Targeted Cryotherapy (Cryosurgery, Cryoablation)

What is prostate cancer?

Prostate cancer is a condition in which malignant cells form in the prostate, one of the male reproductive glands. These cells form a lump or mass called a tumor that can grow directly through the prostate gland and spread cancer cells to surrounding tissue, including the rectum and bladder. This year, over 220,000 new cases are expected to be diagnosed with prostate cancer, or one out of every six men. An estimated 28,900 American men will die of this disease.

How is prostate cancer treated?

Several options are available to treat prostate cancer. Because some men have aggressive forms of prostate cancer, while others have slow-growing cancer, patients should consult their physician to determine which treatment is most effective for the particular stage of their disease. Ideally, the treatment sought for prostate cancer should cure the disease, be easily tolerated and cause minimal problems for the patient for the remainder of his life.

Current treatment options for localized prostate cancer include targeted cryotherapy (cryosurgery, cryoablation), radical prostatectomy, external beam radiation and internal radiation implants (brachytherapy). While radical prostatectomy (removal of the prostate gland) is the “gold standard” for treatment of prostate cancer, many men are considering less invasive treatment options that show equal success, involve faster recovery, less severe side effects and fewer complications. (A comparison of treatment options is outlined at the end of this section.)

How does targeted cryotherapy treat prostate cancer?

Targeted cryosurgery is a procedure developed by Endocare, Inc. It uses the application of extreme cold in combination with ultrasound and temperature monitoring to precisely destroy cancer cells in and around the prostate gland. When extreme cold is introduced into the prostate gland, the prostate tissue is destroyed, including cancerous cells. Physicians have found that targeted cryosurgery is most effective for patients with Stage T1 through T3 prostate cancer (see Important Facts About Prostate Cancer for an explanation of staging). Unlike surgery and radiation, targeted cryotherapy can be repeated if prostate cancer recurs.

During targeted cryo, a patient is first treated with epidural anesthesia. A thin catheter that circulates warm fluid is placed in the urethra to protect it from cold temperatures. Next, six to eight slender cryoprobes are inserted directly through the skin of the perineum into the prostate gland. Liquid argon is circulated at the tips of the cryoprobes, freezing the entire prostate gland. This begins the cooling process, during which the cryoprobes freeze tissue symmetrically around the probe tip. Tissue that reaches -40° Celsius is destroyed. After approximately 10 minutes, the physician completes the first freeze cycle and then administers another treatment to help ensure that all cancer cells are killed. The entire procedure lasts about one to two hours.

What does the patient experience during targeted cryotherapy?

During the procedure, the patient is under either general or epidural anesthesia and experiences no pain.

How does the physician monitor the freezing process?

Endocare’s Cryocare® targeted cryosurgery control unit continuously monitors cryoprobe temperature and treatment time, and physicians use transrectal ultrasound imaging throughout the procedure, enabling clear visualization of the freezing process. Visualization allows the physician to be confident that the entire prostate is destroyed for a successful outcome, while ensuring that surrounding tissues are unaffected. Additionally, the use of argon-based cryogen during the targeted cryosurgery procedure enables the physician to begin or stop freezing instantaneously and to achieve faster and colder freezing.

What happens following the targeted cryosurgery procedure?

Following the targeted cryosurgery procedure, the patient waits in the recovery room until the anesthesia wears off and then, depending on how he feels, can return home immediately or spend the night at the hospital. The patient goes home with a catheter in place to help with urination the week following treatment. In general, patients can resume a normal lifestyle immediately after the procedure but strenuous activity should be avoided for a few weeks.

Some patients may experience soreness or swelling for two to three days following targeted cryosurgery. (This side effect is common among all surgical prostate cancer treatments.) To relieve any soreness or swelling, patients can apply icepacks as directed by their doctor. Long-term side effects of targeted cryosurgery are similar to other therapies and may include impotence, bladder outlet obstruction, pelvic pain, chronic urgency, rectal injury and incontinence. The rate of incontinence after targeted cryosurgery is lower than with other therapies, as with most other long term side effects. Patients should be aware that impotence occurs in 80 to 90% of patients who undergo targeted cryosurgery. 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. However, studies show that 47% of patients regain sexual function as the neurovascular structures regenerate over time.

Freezing tissue beyond the prostate capsule is an important decision that helps in curing the cancer and not leaving behind 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. The nerves that control orgasm, however, are not affected by cryotherapy. Erectile function may be assisted by medication, vacuum device, etc. in order to engage in sex.

What factors are used to assess the success of prostate cancer treatment?

After treatment for prostate cancer, a physician will monitor the disease carefully, checking to see if the cancer recurs or spreads further. A physician uses both a prostate-specific antigen test (PSA) and prostate biopsies following treatment to keep the cancer in check (see Fact Sheet for explanation of PSA). The PSA test can detect elevated levels of the PSA protein while a biopsy shows if cancer is present in the prostate tissue.

How effective is targeted cryotherapy in the treatment of prostate cancer?

In the August 2002 peer-reviewed supplement of the journal Urology results of a seven year study of 590 cryo patients found that 92% of low-risk cancer patients, 89% of moderate-risk patients, and 87% of high-risk patients were disease free. In another study presented at the 1998 World Endo-Urology Conference, 97% of patients treated with targeted cryosurgery showed no signs of cancer at one year. Five-year combined data for both traditional cryosurgery and targeted cryotherapy show that of 988 patients treated, 82% had negative biopsies. This data is especially significant for moderate-to-high risk tumors, which are less successfully treated with surgery and radiation.

Who is a candidate for targeted cryotherapy?

The best candidates for cryotherapy are men with Stage T1-T3 disease. Men with high Gleason scores and PSA levels in particular should consider cryotherapy (see Fact Sheet for an explanation of Gleason scores). In these patient populations, cryotherapy has been found to be safe, effective and medically necessary. Because targeted cryo can be repeated if all the cancer cells aren’t destroyed, some patients choose the treatment for this reason. Others turn to cryotherapy for treatment if radiation therapy or brachytherapy has failed.

How many prostate cancer patients have been treated with cryotherapy?

Thousands of men have chosen cryo to treat prostate cancer. This therapy, first introduced in the 1960s, has seen dramatic improvements during the past eight years with the use of temperature monitoring, argon-based cryogen and ultrasound guidance techniques. The temperature monitoring and ultrasound visualization used in targeted cryotherapy allow the physician to precisely freeze the prostate gland while sparing other critical areas of surrounding tissue. The use of argon-based cryogen provides physicians with better control and accuracy, ensuring that a freezing level of -40°C is achieved and confined to a specific area.

Does Medicare cover the targeted cryotherapy?

Medicare covers targeted cryo for localized prostate cancer (Stages T1-T3). The Centers for Medicare & Medicaid Services (CMS), the federal agency that administers the Medicare program, made this national coverage decision in February 1999 after reviewing new long-term clinical evidence detailing the safety and efficacy of cryo. As a result, Medicare patients with localized prostate cancer qualify for reimbursement for the targeted cryo procedure.


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