Phase 1/2 trial launches of Focal One robotic HIFU for BPH

The first patients have been treated in a phase 1/2 study (NCT06601179) evaluating the safety and efficacy of Focal One robotic high-intensity focused ultrasound (HIFU) in the treatment of patients with benign prostatic hyperplasia (BPH), EDAP TMS SA announced in a news release.¹

Final study completion is anticipated for August 2028.

“We’ve been offering targeted HIFU ablation to prostate cancer patients for more than 15 years,” said Harry Toledano, MD, head of the urology department at Martigues Hospital in Martigues, France, in the news release.¹ “Based on this large experience and the follow-up of hundreds of prostate cancer patients with their functional outcomes, we believe that the HIFU energy precisely delivered by Focal One has the potential to improve BPH symptoms with minimal side effects allowing a quick return to normal activities for a significant number of patients. We are enthusiastic to co-lead the first phase of this important clinical trial with our colleagues from Edouard Herriot Hospital – Lyon University and are looking forward to offering a new option to our BPH patients.”

Phase 1 of the trial is designed to determine the optimal treatment parameters for Focal One robotic HIFU in patients with BPH. Patients in this portion of the trial will be enrolled across 2 clinical trial sites in France. The primary end points for this phase of the trial are the rate of adverse events, improvements in maximum flow, and improvement in obstructive and irritative symptoms, all assessed at the 3-month time point.²

Phase 2 of the trial will then expand patient enrollment to further assess the safety and efficacy of the treatment within the defined parameters. Primary end points for this phase of study include the rate of serious adverse events, improvement in maximum flow, improvement in obstructive and irritative symptoms, and improvement in quality of life, evaluated after 6 months.

Patients will be monitored for up to 36 months.

In total, the prospective, multicenter study will enroll 100 adult patients with BPH.2 To be eligible for enrollment, patients need to be aged 50 to 85 years and have either failed, are ineligible, or refuse medical therapy.

Final study completion is anticipated for August 2028.

“We are excited to initiate this important clinical study evaluating Focal One robotic HIFU for the treatment of BPH, a condition which impacts millions of men each year,” concluded Ryan Rhodes, CEO of EDAP TMS, in the news release.¹ “While there are other treatment options available for treating BPH, there remains a significant need for much less invasive treatment approaches that can preserve and protect the integrity of the urethra and other critical structures. We believe Focal One is ideally positioned to deliver this type of treatment solution, and this clinical approach in addressing BPH represents a logical next step in expanding our technology beyond the application in prostate cancer. We also believe this study will serve as a foundation for initiating a BPH clinical study in the United States next year.”

References

1. EDAP announces first patients treated in phase I/II study evaluating Focal One robotic HIFU for the treatment of benign prostatic hyperplasia (BPH). News release. EDAP TMS SA. October 1, 2024. Accessed October 9, 2024. https://www.globenewswire.com/en/news-release/2024/10/01/2955955/9622/en/EDAP-Announces-First-Patients-Treated-in-Phase-I-II-Study-Evaluating-Focal-One-Robotic-HIFU-for-the-Treatment-of-Benign-Prostatic-Hyperplasia-BPH.html

2. Evaluating the safety and efficacy of the "HIFU" high-intensity focused ultrasound treatment of benign prostatic hyperplasia; (BPH EFFICACY). ClinicalTrials.gov. Last updated September 19, 2024. Accessed October 9, 2024. https://clinicaltrials.gov/study/NCT06601179