By Pete Prunkl

news@salisburypost.com

When Jimmy Higgins walked into his urologist's office, he had just been diagnosed with low-grade, early stage prostate cancer.

Fortunately, it has not spread to other parts of his body. With the intensity of a front-line Marine, he confronted Dr. Wayne Cline, "What would you do if you were in my shoes?"

Cline, of Salisbury Urological Clinic, typically answers this recurring question with two equally important options.

"One recommendation is watchful waiting," Cline said. "Many men do well without treatment. I think we often over-treat prostate cancer."

Statistics are on Cline's side. Less than 20 percent of men ages 50 to 54 with early-stage prostate cancer die from it.

But Higgins, 58, of China Grove, was not interested. He, like a lot of men, didn't want to wait and have something done later when he was older and possibly frailer. He knew he was up against a powerful and deadly enemy and was looking for something that would defeat it.

Bottom line, he wanted a cure.

Cline outlined his choices. The Federal Drug Administration has approved four treatment options: radical prostatectomy (major surgery to remove the prostate), external beam radiation (intense X-rays guided by a computer), internal radiation seeds (80 to 100 radioactive pellets permanently implanted in the prostate) and cryotherapy (freezing the cancerous cells).

Incontinence and impotence rates have been reported as high as 49 and 91 percent with radical surgery. Rates were all over the map for radiation, seed implantation and cryotherapy, with some rates lower and others higher.

As to what Cline would do in Higgins' place, the answer was surprising. Cline told him he would choose none of the above.

Since last fall, for cancer patients like Higgins, Cline has been using a relatively new procedure that the Federal Drug Administration has not approved. To have it done, Cline and his patient have to leave the country for Mexico, where high-intensity, focused ultrasound (HIFU, pronounced high-foo) has been approved.

While Cline remains cautious about the procedure and awaits 15 years of good clinical data, "if I had a low-grade, early stage, localized prostate cancer, it's what I would do," he said.

Higgins listened and opted for HIFU treatment. In October, Higgins, his wife, Sarah and Cline traveled to Puerto Vallarta, Mexico, a coastal city near Guadalajara in the foothills of the the Sierra Madre mountain range.

The high-intensity ultrasound treatment offered a number of clear advantages for Higgins and the 220,000 other American men diagnosed with early prostate cancer annually. It is reported to be fast and effective with a rapid recovery period.

Cline looks at HIFU differently, listing precision as the top advantage. The Sonablate 500, the American-made high-dose ultrasound device he prefers, targets a tiny section of the prostate. The physician controls the entire process, deciding when and where to heat one section and when and where to move on to the next. But like a successful general on the battlefield, the majority of the physician's time is spent mapping the area and planning the attack.

The procedure is quite simple in comparison.

At the Mexican clinic where Cline practices, a patient gets an epidural shot in preparation for the HIFU procedure. That's a spinal block similar to those mothers-to-be receive to reduce the pain of childbirth.

During 4 to 41/2 hours of anesthesia, the patient's legs and abdomen are partially numb.

For the high-intensity ultrasound procedure, the patient lies on his back with his legs elevated. Cline begins not with a scalpel, but with a probe attached to a machine that resembles the Star Wars robot R2D2. He inserts the probe 8 inches into the patient's rectum, where it rests snugly under the prostate.

On a flat-panel screen, Cline views sections of the prostate in images that resemble the familiar fan-shaped pictures new parents receive of their 6-month-old fetus. Cline then directs high-intensity ultrasound to specify overlapping targets.

The probe works like a magnifying glass focusing the rays of the sun to burn a leaf. Temperatures at the target site rise to 195 degrees. Because targeting is so precise, Cline is better able to spare vital non-prostate tissue.

Attached to R2D2 is a chilling device that cools the tip of the probe to prevent overheating of the rectal wall.

There are no incisions and little or no blood. "Cooking the prostate," as patient Higgins describes it, takes from one to three hours. Patients are usually up and around within a few hours and back to work in a couple of days.

"I had no ill effects," Higgins said. "I couldn't tell anything had been done."

Surprisingly, at $25,000, cost is one of the advantages of the high-intensity ultrasound treatment.

"It's one of the cheapest treatments for prostate cancer," Cline said.

According to International HIFU, the Charlotte-based distributor of the Sonablate 500 in the Americas and South Africa, cryotherapy costs $24,000 to $36,000; seeds cost $30,000 to $40,000; radical prostatectomy using robotics costs $35,000 to $74,000; and external beam radiation costs $80,000 to $150,000.

"If there are complications, increase those figures by a third," Cline said.

International HIFU is paying for the Phase II-III clinical trials of the Sonablate 500 in the U.S.

Because the Federal Drug Administration has not approved the treatment, patients typically pay for the HIFU treatment themselves. But more private insurance companies are reimbursing patients.

According to Jenny Hall of International HIFU, 78 percent of Blue Cross Blue Shield patients nationwide who applied for reimbursement got most or all of their expenses returned.

"My Blue Cross policy paid 90 percent," Higgins said.

Cline is one of six N.C. urologists trained in the high-intensity, focused ultrasound treatment and the only one in the Rowan-Cabarrus area.

Dr. Steve Scionti, medical director for the HIFU Care Center in Hilton Head, S.C., trained Cline, who observed 25 HIFU procedures in Mexico. Cline describes his training as "hands-on observation" combined with reading and computer-based DVDs. Each time he performs the procedure, the same registered nurses, physician assistants and engineers from HIFU International accompany him to Mexico.

"It is a full team approach that promotes consistency and safety," Cline said.

Japanese researchers found a .6 percent incontinence rate and incidents of impotence in the low 20 percents with the ultrasound procedure.

Three months after the procedure, British physicians found 92 percent of HIFU patients studied had a low reading — .2 or less — for a prostate antigen indicative of cancer. Higgins tested at .35 on his third three-month checkup after the procedure. He tested 7 to 7.5 before the procedure.

"HIFU is a cure for prostate cancer," Cline said.

So why haven't federal officials approved it?

"The FDA is not being overly cautious," Cline said. The agency is doing its job of testing a new medical device, while Cline has reached his own conclusion.

After his procedure, Higgins opted to keep the details of his prostate cancer largely to himself. He has not attended Rowan Regional Medical Center's monthly Prostate Cancer Support Group.

But others find sharing experiences helpful. The Rowan group is affiliated with Us TOO International, a nonprofit support and advocacy group. Realtor Charles Glover serves as the contact for the group, which meets the third Thursday of every month in the new patient tower and sponsors free prostate screening every September.

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