Boston—Early follow-up of men with localized prostate cancer treated with novel technology that integrates fusion biopsy findings to guide high-intensity focused ultrasound (HIFU [Focal One]) shows the technique has promise for minimizing post-treatment morbidity while providing good cancer control, Italian researchers reported at the AUA annual meeting in Boston.
The device is approved for use in Europe and is currently under FDA review. The single-center study included 41 men with organ-confined prostate cancer and a Gleason score ≥3+3 who were followed prospectively for 6 months after treatment.
Median preoperative PSA was 6.8 ng/mL. Twenty-nine men (70.8%) had low-risk disease, 10 men (24.4%) had intermediate-risk prostate cancer, and two men (5.8%) were in the high-risk category. Median pre-treatment prostate volume was 39.7 mL and median volume of tissue treated was 13.5 mL.
At 6 months post treatment, median PSA was 2.4 ng/mL (range, 0.2 to 9.0 ng/mL), all patients were completely continent, and 30 of 31 men (96%) who were potent preoperatively maintained potency.
Follow-up with multiparametric magnetic resonance imaging (mpMRI) at 6 months identified a focal abnormal signal around the treated area in a single patient. The latter individual underwent fusion biopsy that identified persistence of Gleason 3+3 microfocal cancer and was retreated with the HIFU focal therapy.
“We believe this integrated path for focal fusion treatment that is performed using the latest generation technology for diagnostic imaging and HIFU is allowing the most accurate detection and precise treatment of index foci of prostate cancer,” said Giulio Milanese, MD, a urologist at Ospedali Riuniti, Polytechnic University of the Marche Region, Ancona, Italy.
“Our experience indicates it may optimize functional outcomes. Before focal HIFU can be proposed as first-line treatment for localized prostate cancer, however, longer follow-up is needed to determine its effect on oncological control.”
Localization based on mpMRI, fusion Bx
The procedures were performed at the urology unit of the INRCA Institute of Ancona in collaboration with the department of urology, Polytechnic University of the Marche Region of Ancona between November 2015 and April 2016. Cancer diagnosis and localization in all men was based on mpMRI and 3-D ultrasound-targeted fusion biopsy (Trinity) and standard biopsy. The HIFU platform uses software that directly imports the MRI/ultrasound imaging fusion and delivers the treatment to the intended targets. In order to immobilize the target lesions, the HIFU is performed under general anesthesia.
Median operation time was 105 minutes (range, 80 to 180) and median HIFU exposure time was 70 minutes (range, 35 to 135).
Median hospital stay was 3 days (range, 2 to 5 days). The catheter was removed within 7 days in 33 patients (80%) and kept in until day 15 in the remaining eight men.
Postoperative complications included dysuria in nine men (22%) that was mild to moderate and resolved without any intervention after a median of 7 days. Five men (12.2%) developed a urinary tract infection.
“There were no major complications in this series, and the median International Prostate Symptom Score, which was 8.2 at baseline, was not significantly changed at 6 months,” Dr. Milanese reported.
The study had funding from the National Minister of Health, the Marche Region and Cariverona Bank.
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