Focused ultrasound controls prostate cancer with fewer side effects
NEW YORK 17/06. MRI-guided focused ultrasound (MRgFUS) continues to show promise in men with intermediate-risk prostate cancer, with effective disease control and fewer side effects relative to other treatments, according to new research.
This new treatment strategy has the potential to improve the lives of many prostate cancer patients, Dr. Behfar Ehdaie of Memorial Sloan Kettering Cancer Center, in New York City, told Reuters Health by phone.
"What we did in this study was test rigorously the impact of, in essence, applying the same principles that were applied in breast cancer now three decades ago, in which we do male lumpectomy, or treat only the area in the prostate gland with cancer and preserve the remaining tissue primarily focused on men's quality of life," Dr. Ehdaie said.
The phase-2b, single-arm, multicenter clinical trial enrolled 101 men (median age, 63) with previously untreated grade-2 (79%) or -3 prostate cancer.
"MRI-guided focused ultrasound energy, sequentially titrated to temperatures sufficient for tissue ablation (about 60-70 C), was delivered to the index lesion and a planned margin of 5 mm or more of normal tissue, using real-time magnetic resonance thermometry for intraoperative monitoring," the study team explains in in The Lancet Oncology. All of the procedures were done on an outpatient basis.
At 24 months, 78 of 89 men (88%) who underwent 24-month MRI-targeted biopsy had no evidence of grade-group-2-or-higher prostate cancer in the treated area.
"This is the first step to tell us not only do we achieve the high bar that we set for controlling and treating the disease in the prostate, based on biopsy outcomes in the short term, which was a six month outcomes, but also at 24 months," Dr. Ehdaie told Reuters Health.
"The next step would be to select men and randomize them to this treatment versus monitoring to see how durable that response is out to five years and longer. There is no indication from this study to suggest that patients that have had two biopsies at 24 months post treatment, that there would be changes in their prostate in the in the long term," Dr. Ehdaie said.
Focal therapy was safe and well tolerated, with no grade-4 or -5 treatment-related adverse events and only one grade-3 adverse event (urinary-tract infection). There were no treatment-related deaths.
"No patient had a serious adverse event and no patient experienced urinary incontinence and importantly," at 24 months, 60% of patients had good erectile function without the need of erectile medications and 90% reported good erectile function with or without erectile medication, Dr. Ehdaie told Reuters Health.
The study was funded by Insightec and the National Cancer Institute. Dr. Ehdaie attends the medical advisory board of Insightec as an unpaid consultant, and has previously received consulting funds from Myriad Genetics.
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