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A new, minimally invasive treatment for prostate cancer that freezes the tumor without harming surrounding healthy tissue appears to allow men to remain sexually active and maintain bladder control, potentially eliminating or reducing the incontinence and impotence that plague many men who undergo radical prostate surgery. But both supporters and critics say the treatment is still too new to determine whether it will become a standard of prostate cancer care.

Cryotherapy—using extreme cold to destroy diseased tissue—isn’t a new procedure. It’s been used to blast skin tumors, abnormal cervical cells and liver tumors, but “focal cryotherapy,” or cryoablation, is a new take on this older technique. The procedure uses extreme cold to destroy only the diseased portion of the prostate gland while leaving healthy tissue intact. Focal cryotherapy zeroes in on individual tumors, not the entire gland.

The so-called male lumpectomy involves inserting a probe through a small nick in the skin and using ultrasound, CT or MRI to guide a needle to the tumor. Sub-zero gas is then circulated inside the closed needle tip to freeze and obliterate targeted cancerous tissue. The dead tumor cells are naturally absorbed by the body. Recovery is rapid and men can go home the same day.

Each year, more than 186,000 men learn they have prostate cancer and more than 28,000 die of the disease, according to the National Cancer Institute. Studies of focal cryotherapy first appeared in medical journals in 2002, two years after Medicare approved cryotherapy to obliterate the entire prostate gland. According to interventional radiologist Gary Onik, M.D., of the University of Central Florida in Orlando, approximately 400 physicians currently perform the new procedure in the United States.

“This procedure will gain more acceptance,” predicts Onik, who presented a study of focal cryotherapy this month at a meeting of the Society of Interventional Radiology in San Diego. “I think this is what we’ve been waiting for in prostate cancer.”

What’s in a name?

The few clinical trials for focal cryotherapy have shown low rates of urinary incontinence and impotence (erectile dysfunction), with up to 90 percent of men with cancer on only one side of the prostate retaining sexual function after treatment, according to Thomas Polascik, M.D., a urologic oncologist at Duke University. By contrast, about 30 percent of men have some bladder control problems after either radiation therapy or surgery for prostate cancer; reported impotence rates vary widely, from as low as 10 percent to as high as 80 percent, depending on the person’s age and the type of surgery, according to the American Cancer Society. However, because focal cryotherapy leaves a portion of the prostate untreated, “a cancer in the untreated portion may develop,” Polascik says. And, he notes, there’s currently no way of predicting whether a missed cancer will become aggressive.

Onik did track 120 men between the ages of 50 and 85 who elected to have the procedure as an alternative to a radical prostatectomy or radiation therapy. Follow-up with PSA measurements ranged from one to 12 years, with an average of 3.6 years. (PSA is a screening test that measures the amount of prostate-specific antigen, a protein made by the prostate gland. A raised PSA level can be a sign of prostate cancer.) Of the total, 112 men had no evidence of cancer recurrence. The others developed cancer in a different area of the prostate, which was successfully treated with focal cryotherapy. He reports that 85 percent of the men retained sexual function. Those without previous prostate surgery had no problem with incontinence. Onik owns stock in Endocare, the company that manufactures the focal cryoablation equipment used in the studies.

Brantley Thrasher, M.D., a urologist at Kansas University Medical Center in Kansas City, however, argues that the study wasn’t carried out long enough for a meaningful follow-up. “You need a minimum of 10 years before you can say much,” he says. “I don’t think these data have proven anything.” He adds, “Focal cryotherapy hasn’t been thoroughly investigated in large clinical trials. People will always look at it with guarded skepticism until it’s been time-tested against one of the standards.”

Experts also disagree about who should have the procedure. “Men who have cancer throughout the prostate gland could not benefit from it,” says Polascik. He says that focal cryotherapy is an option mostly for men with small, less aggressive tumors on one side of the prostate. A Duke University study suggests that one in five men has cancer only on one side of the prostate.

Peter Littrup, M.D., an interventional radiologist at the Karmanos Cancer Institute in Detroit, says that if the cancer has not escaped the prostate, the procedure is suitable as long as you can map the tumor, “which makes the mapping crucial and the expertise in following the map even more critical.”

Onik also presented information on a new technique he uses called a 3-D mapping biopsy, which provides a more precise picture of the location of the tumor than the type of biopsy currently used. “A good road map is a must if you want to treat a tumor,” Littrup says. Ultrasound, CT or MRI can provide such a road map for breasts, livers, lungs or kidneys. “But prostate cancer is not that well seen with these imaging techniques. Currently, a 3-D biopsy gives you the best shot of knowing the extent of the disease,” he adds.

Proponents of focal cryotherapy call the procedure a male lumpectomy, comparing it to the breast cancer procedure that removes the tumor, not the entire breast. Critics call the comparison misleading. The premise that this is a "male lumpectomy” is incorrect, says Thrasher. “With a lumpectomy they’re doing something to treat the whole breast with follow-up treatment as well as removing the cancer,” he says. Focal cryotherapy doesn’t include any additional treatment other than watching and waiting.

Each prostate cancer treatment comes with benefits and drawbacks. “Everything depends on how comfortable a man is with his choice,” says Littrup. “I urge patients to be honest with themselves about what they want.” Is retaining sexual potency important? “Then seek out the most effective treatment with the fewest side effects,” he recommends. Is it more important to destroy the cancer completely? Then choose a more aggressive treatment. “Peace of mind is crucial,” Littrup continues. “If you’re honest with yourself about what you want, it’s a lot easier for doctors to be honest with you.”

To Learn More

Mayo Clinic
Prostate cancer treatment and drugs, including focal cryotherapy.

Us TOO International
Prostate cancer education and support.

Nissa Simon, a health writer, lives in New Haven, Conn.