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news.EDAP TMS has received institutional review board approval for Memorial Sloan-Kettering Cancer Center in New York City to participate in its ongoing Phase II/III clinical trial of Ablatherm-high intensity focused ultrasound.
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The prospective non-inferiority study is designed to evaluate the safety and efficacy of EDAP’s Ablatherm-HIFU system versus Cryotherapy for the treatment of low-risk, localized prostate cancer. The clinical trial is currently enrolling men over age 60 diagnosed with clinical stage T1a, b, or c or T2a localized prostate cancer.
The primary outcome measure of the trial will be a statistically significant reduction and stability of the prostate-specific antigen throughout a 24-month follow-up period. This institutional review board (IRB) approval brings the total number of active sites in the trial to 10 high intensity focused ultrasound sites and six Cryotherapy sites.
Marc Oczachowski, EDAP’s CEO, said: “We believe that the quality of participating sites in this trial enhances EDAP’s profile among urologists, which is supported by the continued momentum for our patient awareness trial program to accelerate our screening and recruitment of patients.”