Data offer new insight on HIFU’s use in low-risk PCa

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Transrectal HIFU shows a statistically significant increase in per-core negative biopsy rates.

As the controversy over the use of high-intensity focused ultrasound (HIFU) continues, efficacy research from a device manufacturer offers new insight into how low-risk, low-grade prostate cancer patients fare under the treatment.

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The researchers reported that transrectal HIFU produced a statistically significant increase-from 70.8% to 92.3%-in per-core negative biopsy rates. But lead study author Cary Robertson, MD, cautioned that the findings, from 2007 to 2010, shouldn’t necessarily encourage urologists to embrace HIFU treatment for low-risk patients.

“The landscape is changed, and the patient with intermediate cancer is probably the ideal patient,” said Dr. Robertson, of Duke University Medical Center and Duke Cancer Institute, Durham, NC. He spoke with Urology Times about his study, which was presented at the AUA annual meeting in San Diego.

Last fall, the FDA cleared SonaCare Medical to market its Sonablate 450 device for ablation of prostate tissue. It later approved the marketing of EDAP TMS SA’s Ablatherm device for the same indication.

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The new study findings are being released as urologists continue to debate the value of HIFU in light of the FDA rulings. It’s not a new controversy: In January 2014, a Urology Times online poll found that 46% of respondents didn’t believe HIFU for prostate cancer had a future in the United States. The other 54% thought it did.

Next: 24-month study enrolled 135 patients

The 24-month, prospective, non-randomized study enrolled 135 patients aged 50 years and over with low-risk, localized prostate cancer (stage T1-T2a, PSA <10.0 ng/mL, Gleason score <6) and prostate AP diameter <25 mm. The patients were treated with HIFU via Ablatherm and analyzed via prostate biopsy for cause, 24-month post-HIFU biopsy, and serum PSA.

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The biopsies are unusual, Dr. Robertson said, since surgeons typically rely on PSA results after procedures.

The results: Of 1,251 baseline pre-HIFU biopsy cores, 365 (29.2%) were positive for prostate cancer. After the procedure, 87 (7.7%) of 1,127 biopsy cores were positive.

Before the procedure, mean PSA was 4.60 ng/mL. At 6 months after the procedure, the mean PSA nadir was 0.53 ng/mL.

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As for side effects, “Some patients had inflammatory changes on urinalysis since you’ll get some shedding of some cells,” Dr. Robertson told Urology Times. “Most of the patients didn’t really have any real issues. They had their treatments and a temporary indwelling catheter, and they had that taken out.”

Next: What should urologists take from the research?

What should urologists take from the research? The relevance is limited due to the patient population. According to Dr. Robertson, patients with low-risk, low-grade prostate cancer are “not considered a great treatment category” for HIFU.

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EDAP TMS says HIFU “is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment.”

Dr. Robertson is a consultant and principal investigator for EDAP TMS.