Study Results Build a Case for Prostate Cancer Focal Therapy

Early studies have shown that focal cryoablation results in low overall morbidity and a high rate of sexual potency.

About three decades ago, the debate ensued over universal mastectomy versus lumpectomy in selected patients with breast cancer. The debate raged on until 2003, when the New England Journal of Medicine published an article noting that enough data had been compiled. That study called for acceptance of lumpectomy as the treatment of choice for women with localized breast cancer.

Today, history is repeating itself, with prostate cancer as the focal point—and focal, here, is the operative word. Early studies have shown that focal cryoablation, a minimally invasive method of freezing and destroying only the cancerous portion of the prostate gland while leaving the healthy tissue and nerves intact, results in low overall morbidity and a high rate of sexual potency. This potential new option for prostate cancer patients who have isolated, localized disease can have a huge impact on both cost effectiveness and quality of life for the patient, says Al Barqawi, MD, FRCS, assistant professor in Urology, and director of research at the University of Colorado Health Science Center.

“If I have a radical prostatectomy, I’m going to have a 20 to 30% chance of being incontinent for the rest of my life,” says Barqawi. “Erectile dysfunction is almost 50 to 60% in any radical treatment. On top of that, prostate cancer is one of the biggest budget items in the U.S. health system.”

Mapping biopsy is key

Barqawi explains that the key to determining if an individual is a candidate for focal cryoablation is through a newly developed 3D mapping biopsy of the prostate gland. The mapping biopsy is performed under IV sedation, and the majority of patients recover within 24 hours. To qualify as a candidate, patients should have a small cancer volume of less than 30% of the total prostate volume, localized prostate cancer areas which are confined to the prostate, and the cancer located at safe distance from the vital organs, such as the urethra and rectum.

Barqawi’s concern, however, is that there are surgeons performing focal treatment without a prior 3D mapping biopsy. He explains that over the last 2 years, he has performed 117 mapping biopsies, and almost 50 percent of the patients do not qualify for focal treatment.

“Some [doctors] are doing focal treatment because it’s fashionable,” Barqawi explains. “I spend 2 hours mapping the prostate of my patients before I even tell them they qualify for focal treatment. And if half of them do not qualify, why are these guys offering focal to everyone who walks through the door? Without finding the cancer and localizing it, doing focal treatment is absurd.”

Patient’s perspectiveTwo years ago, Mike Landess received a surprise gift, of sorts, for his 60th birthday. The television news anchorman for KMGH in Denver, Colorado, was diagnosed with prostate cancer. He drew on his journalistic experience and began seeking information, but the initial options he was presented with were unappealing. “I don’t think I’m ready to wear a diaper and give up sex at 60,” he recalled thinking.

Landess also did a story on his situation for broadcast on the news program, and shortly thereafter, he was contacted about the trials being conducted at the University of Colorado Health Sciences Center by Barqawi and his colleague David Crawford. The 3D mapping biopsy made sense, and helped determine that Landess qualified as a candidate for focal cryoablation. The procedure was performed in July 2007. Landess entered the hospital at 6:00 a.m. and was in his car going home before noon. A year later, he’s had no issues or complications as a result of the procedure.

“If they brought me in tomorrow and said there’s more cancer, and it’s bad enough that we need to remove your prostate, it would be gone,” says Landess. “I’ll deal with whatever I need to deal with. But, if I don’t have to do all that, then why would you?”

Slow adoption

A recent survey of more than 140 U.S. and European-based urologists, conducted by Millennium Research Group, found that several minimally invasive prostate cancer treatment options are underused in both the U.S. and Europe. According to the survey, U.S. urologists indicate that cryosurgery is underused, and cited insufficient patient data as the most significant barrier to its adoption.

Barqawi is not surprised. He says that study results on focal cryoablation thus far are few and very short term—no more than a year or two. “They’re very encouraging. From a quality of life preservation aspect, there is absolutely no second-guessing here. It’s great. But I cannot say that we’ve found the answer and that [focal cryoablation] is the standard of care. Not yet.”

However, analysts at Millennium say that despite its current underutilization, the outlook for cryoablation treatment for prostate cancer is positive. They cite improved equipment, a growing body of favorable clinical results, and increased reimbursement rates as factors that will contribute to greater adoption over the next 5 years.

Barqawi, particularly with respect to the technology aspect, agrees. “And once we have that imaging, focal treatment is going to be the treatment of choice.”

Ed Rabinowitz is a veteran healthcare writer and reporter. He welcomes comments at edwardr@frontiernet.net.