Health & Fitness

More and more men are facing a medical conundrum: Either risk losing your sex life forever, or travel abroad for a $20,000 procedure that the FDA hasn’t approved yet.

By: John Brant; Photographs: Nathan Kirkman
Sep 2, 2007 - 8:05:54 PM



Jack Barkin, MD, picks up a scalpel and cuts a quarter-inch incision below the navel of patient Mike Bowman, a 54-year-old medical-equipment salesman from North Carolina. Bowman lies with a spinal anesthetic in a semiconscious sprawl, his legs spread in a stirrup chair similar to those used by obstetricians. Through the incision Dr. Barkin guides a suprapubic catheter into Bowman’s bladder, which will remain in place for a few days after this morning’s procedure until the swelling in the prostate area has subsided. Before this, Dr. Barkin ran a Foley catheter up Bowman’s penis to flush water through the prostate region and to fill the bladder. “For better visibility,” explains Dr. Barkin. “Water is good and air is bad for conducting ultrasound.”
Then Dr. Barkin slides a lubri­cated probe, which is connected to a Sonablate 500 acoustic ablation device, eight inches up Bowman’s rectum. Turning away from his patient—he will not touch Bowman again during the ensuing two-hour procedure—he clicks the mouse of the Sonablate’s computer, firing up the R2-D2–size machine. Deep inside Bowman, the probe shoots out three beams of high-intensity focused ultrasound (HIFU), an energy source similar to what doctors use to dissolve kidney stones. The beams triangulate Bowman’s cancerous prostate, which appears as a fan-shaped gray mass on the computer’s monitor. “This doesn’t look so bad,” says Dr. Barkin. “The cancer is small enough that we can treat it in two sections instead of three.”

Indeed, Bowman’s prostate is in such relatively good shape (meaning that its tumors are well-defined, threatening neither to invade surrounding tissue nor metastasize to distant parts of his body) that if it were 20 years ago, he may not have known he had prostate cancer until it was too late. It wasn’t until 1985 that the FDA approved PSA screening, a test that measures levels of prostate-specific antigen in the blood; an elevated score—from 4 to 10 ng/mL—suggests the presence of cancer. In the absence of early symptoms and timely diagnosis, he may very well have become one of the nearly 30,000 American men who die annually from the disease, the most common cancer among males.

Today, however, patients like Bowman—fit, affluent, sexually active men in their forties, fifties, and sixties with early-stage prostate cancer—are Dr. Barkin’s prime customers. They’re living the short-straw end of the statistics that show that, in North America, men are 35 percent more likely to develop prostate cancer than women are to develop breast cancer, and that by 2015, the number of newly diagnosed prostate-cancer cases will jump to 300,000 a year—a 50 percent increase from today. These medical early adopters have considered every treatment option covered by insurance in the United States—scalpel surgery, radiation, cryotherapy, and brachytherapy—and have chosen instead to pay $20,000 out of pocket to come here, the Can-Am HIFU clinic in Toronto, where Dr. Barkin uses ultrasound to heat their prostate tumors to 212°F, destroying them in less than three seconds. “Basically,” says Dr. Barkin, rather matter-of-factly, “we’re cooking the prostate.”

The speed of the procedure, however, isn’t what will draw an estimated 700 American men across the border to Canada or to clinics in Central America to pay for a treatment that has yet to gain FDA approval. Rather, it’s HIFU’s astonishingly low rate of erectile dysfunction. “I do every kind of prostatectomy, from scalpel to robotics,” says Dr. Barkin, “and the rate of erectile dysfunction with all other treatments, no matter how skilled the surgeon, is around 50 percent. With HIFU, it’s less than 10 percent. Plus, you can’t beat the recovery time.”

At Dr. Barkin’s clinic, which he runs as a sideline to his standard urology practice at Toronto’s Humber River Regional Hospital, men are treated as outpatients on Saturday. On Sunday, most feel well enough to go sightseeing.

The operating room is small, brightly lit, and oddly cheerful, seeming more like a dentist’s office than a place of life-or-death stakes. Content that the procedure is proceeding smoothly, Dr. Barkin, an inveterate teacher, launches into a quick lecture on the walnut-shaped gland that is the prostate. The first spurt of an ejaculation comes from the prostate, he explains, whose evolutionary function is to secrete enzymes that protect sperm from acids in the vagina. All male mammals possess a prostate. In humans, it sits at the crossroads of several crucial organs: the rectum, anus, bladder, urethra, and seminal vesicles. Two razor-thin bundles of nerves run vertically along both sides of the prostate and are largely responsible for stimulating and preserving erections. “Here you can see them plain as day,” says Dr. Barkin, pointing out two faint dark lines on the monitor. I fix my eyes on the glowing computer screen, which shows sonic beams systematically zapping Bowman’s tumors into benign scar tissue, which possesses an eerie resemblance to cooked popcorn.

Bowman’s long journey to this fifth-floor cancer clinic—marked only by a hastily word-processed sign next to the elevator—began three months earlier, in July, on the day that his prostate biopsy returned positive. “My first thought was, I’m going to die,” recalls Bowman. “My second was, Why me?” After the initial shock and subsequent pulse of anger, Bowman confronted his first fateful choice: Treat or not treat? Take out the gland that delivers a man so much pleasure during the first half of his life, and so much anxiety later, or proceed with watchful waiting?

The concept of watchful waiting, in which a physician closely monitors an untreated prostate-cancer patient for spiking PSA levels or other signs that the malignancy threatens to spread, never appealed to Bowman. At 54, he was in his prime, in good shape, and with many good years ahead of him—years, reckoned Bowman, that could allow his cancer to spread insidiously into other organs, his liver perhaps. Or maybe the cancer would beeline for his colon before heading north to his lungs.

Many physicians would argue that Bowman’s concern was for naught. In the great majority of cases, prostate cancer is so slow growing that Thomas Stamey, MD, the Stanford University urologist who pioneered PSA screening, has been reported as saying that up to 90 percent of the prostatectomies performed during the last decade were unnecessary. Indeed, only one in four men with latent prostate cancer will ever show symptoms, even if left untreated, and there is a less than 20 percent chance that men ages 50 to 54 with early-stage prostate cancer will die from it. Moreover, no long-term studies have proved definitively that treating prostate cancer increases longevity. Mountains of data, by contrast, attest to treatment’s bleak side effects, the most prominent being the likelihood of erectile dysfunction and urinary incontinence.

What bothered Bowman, however, was that despite intense ongoing research, there’s no reliable way to predict the nature of a prostate tumor—whether it’s among the aggressive 25 percent that kills, or the more benign 75 percent that rarely produces symptoms. “I can understand the statistical argument, but from a personal survival standpoint, the whole idea of ‘­watchful waiting’ seems absurd,” says Bowman. “Wait for what? For the tumors to magically dry up and go away, like warts? Or for the cancer to invade my spine and liver, and then decide it’s time to treat it?”

As recently as a decade ago, scalpel prostatectomy, which was pioneered in the 1940s, was the standard treatment for prostate cancer, and excising the malignancy—nerve bundles and all—was the surgeon’s primary, and often sole, concern. In their defense, surgeons had little choice in the matter. Most men seeking treatment back then had reached stage II of the disease, and since their cancer had already spread, saving their lives almost always entailed removing the gland. Today, however, with PSA screening standard for men older than 50 and early diagnoses increasingly common, the effort to save those delicate nerve bundles—through techniques such as nerve-sparing radical prostatectomy, robotic surgery, and now HIFU—has blossomed into a multibillion-dollar industry. In short, men with prostate cancer finally have a say regarding the preservation of their sex gland.

“One guy might say, ‘This cancer freaks me out. Cut it out with a knife and damn the consequences,’ ” says Dr. Barkin. “A second man might want every precaution taken to preserve the nerves and erections by being less aggressive, but if the moment comes, err on the side of killing the cancer. A third man might say he’d rather die than live with erectile dysfunction. And men do die for that reason. You’d be surprised how many.”
 
The sheer number of available prostate-cancer treatments—there are six mainstream options—initially bewildered Bowman, and, like many newly diagnosed men, he spent weeks studying the voluminous and contentious literature on the subject. “I worked day and night,” he recalls, “but I never seemed to get tired. I felt like I was in a war, fighting for my life. And just like war, there was the fog: too much information.” He obsessively surfed Web sites, interviewed a range of urologists, and discovered that, invariably, each one recommended his own pet procedure.

This was due partly to the confidence each physician had in his craft, but it would be naive to assume that none of them had an eye on financial gain. National spending for prostate-cancer treatment, after all, is about $8 billion annually. And the more patients a physician treats, the bigger his piece of the prostate-cancer pie. What was once an unglamorous medical specialty has, in the last 20 years, developed into one of the most lucrative.

While none of the six standard treatment options are guaranteed to cure prostate cancer, all are effective. A study in the New England Journal of Medicine, for example, showed that prostate-cancer patients who underwent surgery were 44 percent less likely to die from the disease than men treated by watchful waiting. But life expectancy wasn’t Bowman’s chief concern. “I just didn’t want to lose my potency, and no conventional treatment could offer the successful statistical outcome I wanted in that regard,” says Bowman. “In fact, having prostate cancer brought home the degree to which sexuality permeates everything I think and do. Your sex is who you are, to a certain extent. And I never quite realized that until I was in danger of losing it.”

Bowman first learned about HIFU while researching on the Web. The more he learned about it, the better it sounded. HIFU technology was first used to treat prostate-cancer patients in France in the 1990s, and was refined by researchers at the Indiana University School of Medicine, who developed the first version of the Sonablate machine. To date, HIFU has been used on more than 20,000 patients worldwide, and the Sonablate 500 scored a success rate of 94 percent in patients with low-grade localized cancer, according to recent research by Toyoaki Uchida, MD, of Japan’s Tokai University.

“In the course of my sales work,” says Bowman, “I’ve sat in on a lot of surgical procedures and seen things I’d like to forget. For my own surgery, I wanted the least invasive, most controllable procedure possible.” But Bowman quickly learned that this favorite treatment of aging rock stars, airline pilots, and, intriguingly, American physicians, comes with a significant catch: It’s not offered in the United States (nor is it covered by U.S. insurers, for that matter). To receive it, one must travel to Europe, Japan, Mexico, or Canada and pay a fortune in medical expenses.

Bowman’s plight raises an important question: Why isn’t HIFU available in the United States? “The FDA is very rigorous when it comes to clinical trials for cancer treatment,” explains Naren Sanghvi, who helped develop the Sonablate machine. “In the case of the Sonablate 500, studies must prove unequivocally that it resolves prostate cancer. Then researchers must follow the trial participants for years to determine that the cancer doesn’t recur.” In the United States, such data has been slow in coming. The Canadian government approved the procedure in 2004, but it is not covered by national health insurance because Health Canada is still waiting on 10-year results and it pays for the other treatments that are currently as effective.

In the summer of 2006, the Sonablate 500 passed the first round of testing in the United States, which deemed it safe for clinical trials. Last spring, clinical trials began at two clinics in Tennessee and one in Texas. To enroll, visit focus-surgery.com. According to Sanghvi, test data will be gathered and evaluated over the next several years, and if all goes well, FDA approval will follow within the next decade. “Every American urologist who looks at HIFU is intrigued,” says Ian Thompson, MD, chair of the urology department at the University of Texas Health Science Center at San Antonio. “But the big question, and the greatest hurdle for FDA approval, is whether HIFU can be proved to cure prostate cancer. And that takes time.”

Once the procedure is complete, it takes Bowman several minutes to shake off the anesthesia. He emerges groggily, feeling his way back into reality bit by bit, almost at the pace it took the Sonablate to cook his prostate. News that the procedure was a success takes a while to sink in. He is reluctant to sit up in bed, let alone take his first steps down the hallway toward the recovery room, but once he gets his legs under him, he feels a surge of relief and energy. He vows that when he returns to Charlotte he will mount the soapbox about prostate cancer.

“The week before the Komen Foundation’s Race for the Cure, you couldn’t turn on the television or walk down the street without hearing about breast cancer,” he says. “Well, September is National Prostate Cancer Awareness Month in the United States. Are you aware of that fact? I didn’t think so.”

Then, in midafternoon, almost exactly seven hours after Mike Bowman entered the clinic, Dr. Barkin gives him the okay to leave. Bowman accepts a nurse’s arm in the elevator, but once out on the sidewalk and tasting the cool autumn air, he lets go. The nurse urges him to move cautiously, to cross Bay Street at the traffic light, but Bowman, declaring that he’s ravenous, is eager to get back to his hotel.
 
“Hell, let’s jaywalk,” he says, stepping lightly off the curb.

Three days later, back home in Charlotte, Bowman’s bladder function returns to normal and a doctor removes his catheter. The next night, his greatest fear regarding prostate-cancer surgery is laid to rest .



© Copyright 2007 Best Life Magazine