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Prostate Cancer And Its Treatment:
A Situation Analysis

I. The Disease

Prostate cancer is the second leading cause of cancer-related death in men, exceeded only by lung cancer. According to the American Cancer Society, nearly 221,000 new cases of prostate cancer—one out of every six men—will be diagnosed in the U.S. in 2003. An estimated 28,900 men will die from the disease. Those at risk are men aged 50 and older, African-American men, and men who have had immediate relatives diagnosed with the disease. Prostate cancer has long been a "quiet killer" since it may have no symptoms until it is at an advanced stage. Until recent years, the topic has been absent from public discourse. As awareness of this life-threatening disease has grown, demand for improved treatment alternatives has increased. As of July 1, 1999, Medicare covers cryotherapy, a curative procedure that preserves a patient's quality of life.

II. Current Treatment Options

Thanks to a simple PSA (prostate specific antigen) blood test, 60% of cases are diagnosed while the cancer is still confined to the prostate gland. If detected early, the survival rate for patients after five years is 100%. Many treatment options are available, ranging from "watchful waiting" to removal of the prostate (radical prostatectomy), and from radiation therapy (external beam or implantable pellets) to cryotherapy.

It is imperative that a patient has enough information to make an informed decision with his physician about the most appropriate treatment plan. Many treatments, although highly effective, may have severe side effects or complications that raise significant questions regarding the patient's quality of life. Several considerations must be made when determining the most suitable treatment for prostate cancer: the patient's age and stage of the disease, the risk of recurrence, treatment cost, side effects and the overall impact on the patient's quality of life.

After initial diagnosis of prostate cancer, the physician will determine the stage of the disease and the rate at which it is spreading. The stage, or extent, of the cancer is classified from stages T1 (still confined to the prostate) through T4 (spread beyond the prostate). A Gleason score between two and 10 is then assigned to determine the aggressiveness of the tumor. The higher the score, the more likely the cancer will grow and spread rapidly.

A) Watchful Waiting

If it has been determined that the cancer is in a very early stage, is expected to grow slowly and is not causing any symptoms, a "watch and wait" approach may be recommended. This method of monitoring the tumor's growth allows the patient to defer treatment, sparing him the risk of potentially harsh side effects. Although treatment may become necessary at some point, this may be an appropriate option for older men with small tumors that are expected to grow slowly. Some physicians may also recommend this for older men who, as a result of a pre-existing medical condition, may not be able to tolerate the side effects or complications of treatment.

B) Radical Prostatectomy

The most common prostate cancer treatment is radical prostatectomy. The "gold standard" of treatment, a radical prostatectomy involves surgically removing the entire prostate and some surrounding tissue. This surgical procedure is highly effective, especially for low-risk tumors, but is also the most invasive treatment.

A radical prostatectomy involves a hospital stay of several days and a recovery period of several months. Because it is a major surgical procedure, radical prostatectomy may not be appropriate for all patients, such as those with pre-existing medical conditions. Also, it has the highest complication rate of all available treatments. Impotence and incontinence are likely side effects of this procedure. Post-operative studies indicate that 22% of patients treated with radical prostatectomy had evidence of the disease long-term1.

C) Radiation Therapy

Radiation therapy—external beam radiation or internal radiation (brachytherapy)—is another common treatment that can be used to treat cancer that is confined to the prostate or has spread to nearby tissue. Radiation therapy uses high-energy rays or permanent implantable radioactive "seeds" to destroy cancer cells. Many patients choose radiation therapy because it presents fewer complications than radical prostatectomy and is less invasive.

External beam radiation generally requires treatment five days a week for six to eight weeks. Side effects can include fatigue that does not dissipate for one to two months following treatment and incontinence. Brachytherapy involves implanting radioactive pellets into the prostate that give off radiation for several weeks to months. Because of the toxicity of the radioactive materials, this treatment assumes the risk of radiation exposure to the patient and his family and can also lead to significant rectal problems. Clinical data show positive biopsy (recurrence of cancer) in 22% of brachytherapy patients2. Salvage radiation therapy is not recommended if there is a recurrence of the disease.

D) Cryotherapy (Cryosurgery, Cryoablation)

Cryotherapy is an effective yet minimally invasive alternative to surgery and radiation therapy. It uses slender probes, called cryoprobes, to deliver a lethal freeze to destroy the tumor and surrounding tissue. Under ultrasound guidance the probes are inserted through the skin and are strategically placed in and around the prostate to target the entire gland and minimize damage to surrounding healthy structures. A warming catheter protects the urethra while the probes freeze the cancerous tissue at temperatures of -40° Celsius. The procedure is done under either general or epidural anesthesia. Since it is minimally invasive, it offers patients a quicker recovery and reduced severity of potential side effects such as incontinence. Without the expense associated with major surgery or an extended hospital stay, cryosurgery is a cost-effective treatment option.

Recent technological advancements have introduced a safer and more effective cryosurgical procedure called Targeted Cryoablation of the Prostate (TCAP). TCAP uses between six and eight ultrasound-guided cryoprobes to deliver a lethally cold temperature to specific areas. The resulting iceball that forms insures that all cancer cells are immediately destroyed. It also uses thermosensors that enable physicians to monitor the process and determine when exact target temperatures have been reached. The treatment is highly effective for low, moderate and high risk localized prostate cancers. Freezing kills cancer cells on contact regardless of how aggressive they are.

Impotence is an expected side effect of targeted cryosurgery due to the freezing of tissue outside the gland to kill cancer cells that may have spread. This safety measure reduces the possibility of any additional tissue becoming malignant. New nerve-sparing procedures can preserve sexual function after cryotherapy for qualified patients. Unlike radical prostatectomy or radiation therapy, cryotherapy can be repeated if necessary. Clinical data indicates that for locally confined prostate cancer, cryotherapy offers the highest average long-term success rates across all stages of localized prostate cancer. This targeted freezing procedure is minimally invasive, enabling patients to sustain the highest quality of life possible.

III. Medicare Coverage of Prostate Cancer Treatments

With treatment costs soaring as high as $30,000, radical prostatectomy and radiation therapy—which are regularly covered by Medicare—have long been the only treatment options available to prostate cancer patients. Beginning July 1, 1999, The Centers for Medicare & Medicaid Services (CMS) approved cryotherapy as a new treatment alternative to Medicare beneficiaries by providing national coverage for the procedure as a primary treatment for localized cancer. The implementation of Medicare policy was based on highly successful clinical results, and validates cryosurgery as an effective primary treatment option for prostate cancer. Cryotherapy is also the only Medicare-approved "salvage" treatment for post-radiation prostate cancer recurrence.

  1. Elgamal et al. "Ten-year disease free survival after transperineal sonography-guided treatment." Cancer. 83:989-1001. 1998.
  2. Ragde, Cancer. 83(5):989. 1998.

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