Study shows HIFU safe, effective ablation option in prostate cancer

Use of focal high intensity focused ultrasound (HIFU) was shown to be effective and safe in patients with localized prostate cancer, according to findings published in the Journal of Urology.¹

At a minimum follow-up of 12 months, 83% of patients receiving HIFU had negative in-field biopsy results. Thirteen percent of patients had de-novo positive out-of-field biopsy. There were no complications above grade 3, and only 5 total grade 3 events occurred. Within 3 to 6 months of treatment, questionnaire scores returned to baseline levels for urinary symptoms, and sexual function scores returned to baseline levels by 12 months.

HIFU demonstrated “Acceptable short-term oncologic and functional outcomes. The complications are minimal and patient selection is essential. Short-term oncologic outcomes are promising but longer follow-up is required to establish long-term oncologic outcomes,” the investigators wrote.

The single-center, prospective study assessed data for 52 patients who received primary focal HIFU between January 2016 and July 2018.The median patient age was 67 years (range, 49-88), the median patient PSA level at baseline was 5.5 ng/ml (range, 1.6-25.9), and the median prostate volume on TRUS was 34 (range, 14-84).

Overall, 67% of patients had tumors that were Grade Group (GG) 2 or greater. At baseline, there were 17 patients in GG1 (Gleason, 3+3); 24 in GG2 (Gleason 3+4); 6 in GG3 (Gleason, 4+3); 3 in GG4 (Gleason, 8); and 2 in GG5 (Gleason, 9-10). Cancer location included apex (n = 7); middle (n = 4); base (n = 2); apex + middle (n = 14); apex + base (n = 3); middle + base (n = 8); and apex, middle + base (n = 14). Prior to receiving HIFU, 28.8% (n = 15) of patients had tumor debulking with holmium laser enucleation of prostate or transurethral prostate resection.

All patients received ablation with the AblathermHIFU device (EDAP).² The primary end point was oncologic control, which the study design defined as negative follow-up infield biopsy of treated cancer.

The efficacy findings reported were for 30 patients who underwent biopsy, of whom 25 (83.3%) had negative infield results. Five (16.7%) patients had positive infield biopsy results. There were 4 (13.3%) patients who had de novo positive out-of-field biopsy and negative infield biopsy. Eight of the 9 patients with a positive biopsy received active surveillance for low-risk disease. The other patient needed salvage prostatectomy after disease progression was detected on his 2-year biopsy.

Overall, PSA levels were significantly reduced, with 80.3% of patients achieving a PSA low-point of <2 ng/ml.

Among the 52 patients, there were 32 complications, including 27 grade 1/2 and 5 grade 3 (occurring in 4 patients). Across all grades, urinary tract infection (38.5%) was the most common complication. Conservative management was able to resolve obstructive symptoms in the 4 patients experiencing these complications for more than 15 days. During the study, there were no cases of metastases observed or patient deaths.

“Focal therapy using HIFU may be offered as an alternative to the existing modalities of treatment for select patients with all risk profiles of prostate cancer. The short-term oncologic and functional outcomes are effective with acceptable complication profiles,” the authors wrote in their conclusion.

For more on HIFU, listen to 2 of our recent podcast episodes with Dr. Samuel J. Peretsman.

References

1. Nahar B, Bhat A, Reis IM, et al. prospective evaluation of focal high intensity focused ultrasound for localized prostate cancer. J Urol. 2020 Sep;204(3):483-489. doi: 10.1097/JU.0000000000001015

2. EDAP Announces Two Publications Highlighting Favorable HIFU Focal Therapy Outcomes in Journal of Urology. Published August 18, 2020. https://bit.ly/34er8nPAccessed August 20, 2020.