May 22, 2020

MR-Guided Focused Ultrasound Therapy Is Effective for Grade Group 2, 3 Prostate Cancer

By Eric Ramos

CHICAGO -- May 22, 2020 -- Magnetic resonance-guided focused ultrasound (MRgFUS) focal therapy using real-time MR thermometry is effective for grade group 2 and 3 prostate cancer, according to a study presented at the 2020 American Urological Association (AUA) Virtual Meeting.

This approach may enable men to consider a tissue-preserving approach and defer or avoid radical therapy, said Behfar Ehdaie, MD, Memorial Sloan Kettering, New York, New York.

“Patients with grade group 2 or 3 prostate cancer are often ineligible for active surveillance or experience early disease progression leading to surgery or radiation,” he said. “Focal therapy has emerged as an alternative treatment with the goal to reduce side effects and maintain cancer control by targeting areas of known cancer with the prostate gland. We investigated whether targeted focal therapy using ExAblate MrgFUS can safely treat patients with Gleason grade group 2/3 prostate cancer.”

From May 4, 2017, to December 21, 2018, 101 men (mean age, 63 years) with unilateral, MRI-visible intermediate-risk prostate cancer confirmed on MR-targeted systematic biopsy received MRgFUS to the grade 2 or 3 lesion, with a margin of normal tissue (=5 mm). The treatment was monitored with real-time MR thermometry. Concurrent grade group 1 prostate cancer foci were untreated

“No serious treatment-related adverse events were observed,” said Dr. Ehdaie. “The majority of minor or moderate adverse events were self-resolving.”

At the 6-month MR-targeted systematic biopsy, 91% of men had no evidence of any prostate cancer in the treatment area. Importantly, 96% of men had no evidence of grade group ≥2 prostate cancer in the treatment area.

The overall evaluation of the entire prostate gland showed that 78% of men had no evidence of any grade group ≥2 prostate cancer anywhere in the prostate gland, including prostate cancer detected outside of the treatment area.

Serum prostate-specific antigen (PSA) measurements decreased by almost 50% after treatement and stabilised after 6 months.

Median overall International Index of Erectile Function-15 (IIEF-15) erectile function scores were slightly lower at 12 months versus baseline (mean score difference of -3.50), as were mean intercourse satisfaction and overall satisfaction.

Lower urinary tract symptoms, assessed by International Prostate Symptom Score (IPSS), were similar at baseline and at 12 months, as was quality of life scores.

“ExAblate MRgFUS focal therapy using real-time MR thermometry preserves urinary continence and sexual function, and is effective for grade group 2 and prostate cancer based on 6-month biopsy outcomes,” said Dr. Ehdaie.

He noted that 24-month protocol mandated prostate biopsy data is currently being collected.

Funding for this study was provided by Insightec, Inc.

[Presentation title: Phase IIb Multicenter Study on MRI-Guided Focused Ultrasound (MRgFUS) Focal Therapy for Intermediate Risk Prostate Cancer. Abstract LBA02-06]
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