HIFU

Transrectal High Intensity Focused Ultrasound : Ablatherm is a medical device piloted by a computer designed to treat localized prostate cancer using high intensity focused ultrasound (HIFU). Ablatherm® HIFU is a procedure where the temperature inside the prostate is raised to 85° Celsius using a focused ultrasound beam. Under a spinal or epidural anesthetic an ultrasound probe is inserted in the rectum to map the exact outline of the prostate gland. Using this map, high intensity ultrasound waves are delivered through the rectal wall precisely focused on the prostate. This focusing produces intense heat and causes the destruction of the tissue inside the targeted zone without damaging surrounding tissues. The treatment generally takes 1 to 3 hours depending upon the size of the prostate and is usually performed on an outpatient basis.

Is My Cancer Curable by Treatment with Ablatherm® HIFU?

Ablatherm® HIFU is an appropriate treatment option for essentially any male who has prostate cancer which can be cured by any other means. The stages of cancer of the prostate are:
1.T-1 Prostate cancer - This is a cancer which has no signs or symptoms and is totally unsuspected. The prostate feels normal to the physician on rectal exam. The cancer is detected either by an elevated Prostatic Specific Antigen (PSA) blood test and subsequent biopsies or by examination of tissue removed during treatment of an enlarged prostate. This tumor can be cured by surgery, radiation, and Ablatherm® HIFU.
2.T-2 Prostate cancer - This is a tumor which is suspected on rectal exam. One or both lobes of the prostate have areas of firmness and biopsies reveal the cancer. The PSA is also usually elevated. This tumor can be cured by surgery, radiation, and Ablatherm® HIFU.
3. T-3 Prostate cancer - This is a tumor that has spread outside the prostate capsule and may have reached the seminal vesicles. This tumor is not curable by surgery, radiation, or HIFU.
4.T-4 Prostate cancer - This tumor may have spread to the rectum or bladder or to distant organs or bone. This tumor is not curable by surgery, radiation, or HIFU.

Patients with both T-1 and T-2 prostate cancer will have an imaging scan, such as an MRI or CT, to try to detect cancerous extension outside the prostate or to other organs (lymph nodes, liver, etc.). A Bone Scan is used to rule out spread to bone. These tests will show no spread of tumor outside the prostate in T-1 or T-2 cancer.

Patients with T-1 and T-2 prostate cancer who have had external beam radiation therapy (EBRT) and recurrent cancer, but no spread outside the prostate, can be treated for cure by Ablatherm® HIFU. The sooner a patient is treated after the diagnosis of failed EBRT the better the chance he has for cure by Ablatherm® HIFU.

Patients with T-1 and T-2 prostate cancer who have had a radical prostatectomy and have recurrent cancer localized to the area of the prostatic fossa can be treated for cure by Ablatherm® HIFU. In fact, Ablatherm® HIFU remains one of the only therapy options for these patients.

It is important to know that the ability to detect microscopic spread of the tumor beyond the walls of the prostate is limited by today's technology. It is estimated that approximately 30% of patients diagnosed as having T-2 prostate cancer actually have a spread of cancer cells outside the prostate wall (T-3) and are therefore not curable. This is particularly true if the PSA is equal to or greater than 10 or the Gleason score is greater than 7.

What Do the Clinical Studies Show?
Ablatherm® HIFU has been extensively used in Europe. One report of 137 patients showed that 93% of the patients had negative prostate biopsies and 87% had PSA levels of less than 1.0 five years after the treatment.

Over 90% of patients undergoing Ablatherm® HIFU therapy will not require further treatment for their prostate cancer. Indeed, among the patients treated by Maple Leaf HIFU, fewer than 3% of patients have required retreatment in our first two years of operation. In those developing a recurrence, they remain candidates for surgery, radiation or hormone therapy. Ablatherm® HIFU treatment has a similar success rate to radical prostatectomy but has the major advantage of using non-invasive technology with many fewer side effects.

Is Ablatherm® HIFU a Proven Therapy?
In 1989, three prestigious European research groups united in their efforts and initiated a project to develop an efficient and non-surgical treatment for localized prostate cancer. After ten years of development Ablatherm® HIFU was approved for treatment in Europe. At present, Ablatherm® HIFU is being used throughout Europe, Russia and other Asian countries. To date, thousands of patients have been treated successfully in many European centers and throughout the world.

What are the Benefits of Ablatherm® HIFU?
The treatment of localized prostate cancer with High Intensity Focused Ultrasound has many advantages:

• Destruction of the cancerous tissue with no incident of injury to the rectum since parameters were updated in 2002.
• Patient does not undergo any radiation exposure.
• No hospital stay is required.
• Treatment is performed under spinal anesthesia.
• Treatment can be repeated if necessary.
• Other therapeutic alternatives can be considered in case of incomplete results.
• Ablatherm® HIFU can be used for the treatment of local recurrences (i.e. after external beam radiotherapy).