Alpha Tau Medical Ltd., the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, announced that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with locally recurrent prostate cancer using the Company’s Alpha DaRT technology.

“We are excited to bring the Alpha DaRT technology to prostate cancer patients in the U.S.,” said Dr. Robert B. Den, Alpha Tau Chief Medical Officer. “According to the National Cancer Institute, over 300,000 new cases of prostate cancer will be diagnosed in 2025, and clinical literature indicates that up to 15% of patients treated with external beam radiation therapy can develop local recurrence within 15 years of treatment. We look forward to exploring Alpha DaRT as a new local salvage therapy for patients with recurrent prostate cancer, as an alternative to systemic androgen deprivation therapy.”

The clinical trial is expected to enrol up to 12 U.S. patients with locally recurrent prostate cancer who have demonstrated biochemical recurrence by the Phoenix definition (a rise of PSA levels by 2 ng/mL from the PSA nadir). The primary objective of the study is to evaluate the safety of the treatment, following the Company’s promising results from clinical study treatments in Israel, and the secondary objective of the study is to evaluate the efficacy of Alpha DaRT as assessed by biochemical and clinical evaluation of disease progression, as well as overall survival.

“With this IDE approval, our fifth in the U.S. currently active, Alpha Tau continues to broaden its reach in the U.S. across a range of tumour types. We have repeatedly heard the demand from clinicians and patients who want a new, focused alpha-radiation-based local salvage therapy for prostate cancer, and are eager to explore the benefits that Alpha DaRT may bring to recurrent prostate cancer patients, who currently face several poor available alternatives,” added Alpha Tau Chief Executive Officer Uzi Sofer.