A new InSightec study to determine feasibility and safety of using the ExAblate System to treat localized, low-risk prostate cancer has begun in California. Jeffrey Wong, MD, Professor and Chair of the Department of Radiation Oncology and Associate Director of the Prostate Cancer program at City of Hope in Duarte, California is the principle investigator at City of Hope. The study will begin enrolling at the Mayo Clinic in Rochester, Minnesota, and other locations. City of Hope is the first U.S. site to treat a patient enrolled in this study.
At City of Hope, Dr. Wong performed the first treatment in November of last year. He treated the second patient this month, and a third will be treated soon. “The treatments went well – the technology performed well,” he said. “We visualized the area to be treated, and the software helped focus on our target tissue.” Dr. Wong wrote a blog post after treating the first patient in the study, and Imaging Technology News also wrote a story about the study.
After the procedure, which took about 4 hours including anesthesia and preparation time, the patient was very pleased and had no issues with urination or erectile function. The length of the treatment is similar to a standard seeding prostate cancer, about the same time as a brachytherapy. The patient who was treated in November just underwent his six-month biopsies, and there were no signs of cancer.
The clinical trial is designed to assess the feasibility and safety of focused ultrasound therapy in patients with low-risk prostate cancer. Traditional options include active surveillance or surgery, or other treatments like brachytherapy that treat the entire gland. The new strategy is to treat only the portion of the gland with the cancer and potentially eradicate the entire tumor burden or delay time to progression. If this study demonstrates safety and feasibility, then future, larger studies will assess the effectiveness of focused ultrasound to possibly offer a side-effect profile that is improved over standard therapy. For comparison, EDAP-TMS’s Ablatherm focused ultrasound system is also designed to treat low-risk, localized prostate cancer but their approach targets the whole prostate gland.
The study will treat 40 patients at up to 7 different sites in the U.S., including the Mayo Clinic. Men who are interested in participating should contact either City of Hope or the Mayo Clinic. ClinicalTrials.gov will be updated as additional locations are added.