Alpha Tau Receives FDA Approval for Prostate Cancer Trial and Presents Pancreatic Cancer Data at ASCO
核心洞察
Alpha Tau Medical received FDA approval for an Investigational Device Exemption to initiate a pilot study treating locally recurrent prostate cancer patients with Alpha DaRT (搜索) technology.
The prostate cancer trial will enroll up to 12 U.S. patients with biochemical recurrence, aiming to evaluate safety and efficacy as an alternative to systemic androgen deprivation therapy.
Two abstracts on Alpha DaRT (搜索) pancreatic cancer research will be presented at the 2026 ASCO (搜索) Gastrointestinal Cancers Symposium, demonstrating continued progress in this high unmet need indication.
Alpha Tau Medical Ltd. has received FDA approval for an Investigational Device Exemption (IDE) to initiate a pilot study treating patients with locally recurrent prostate cancer using its Alpha DaRT (搜索) (Diffusing Alpha-emitters Radiation Therapy) technology. The approval marks the company's fifth active IDE in the U.S., expanding its clinical reach across multiple tumor types.
Prostate Cancer Trial Details
The clinical trial will enroll up to 12 U.S. patients with locally recurrent prostate cancer who have demonstrated biochemical recurrence by the Phoenix definition, characterized by a rise of PSA (搜索) levels by 2 ng/mL from the PSA nadir. The primary objective focuses on evaluating treatment safety, building on promising results from clinical studies conducted in Israel. Secondary objectives include assessing Alpha DaRT (搜索) efficacy through biochemical and clinical evaluation of disease progression and overall survival.
"We are excited to bring the Alpha DaRT (搜索) 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."
The treatment aims to provide a new local salvage therapy alternative to systemic androgen deprivation therapy for patients with recurrent prostate cancer, who currently face limited treatment options.
Pancreatic Cancer Program Advances
Alpha Tau announced that two abstracts have been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO (搜索)) Gastrointestinal Cancers Symposium, scheduled for January 8-10, 2026 in San Francisco. The abstracts, titled "Feasibility, Safety and Efficacy of Endoscopic Ultrasound-Guided Alpha Radiotherapy for Advanced Pancreatic Cancer: A Pilot Study" and "Inflammatory and Immune Marker Dynamics following Intratumoral Alpha DaRT (搜索) for Pancreatic Cancer," will be presented by investigators from the company's recently completed pancreatic cancer pilot trial in Montreal, Canada.
The company treated its first patient in a U.S. multi-center pancreatic cancer clinical trial in September 2025. The trial expects to enroll up to 30 patients with newly diagnosed pancreatic cancer, addressing a critical unmet medical need as up to 87% of newly diagnosed pancreatic cancer patients are considered inoperable at diagnosis and face a dismal prognosis with limited benefit from existing therapies.
Alpha DaRT Technology
Alpha DaRT (搜索) technology delivers highly potent and conformal alpha-irradiation to solid tumors through intratumoral delivery of radium-224 impregnated sources. When radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles designed to destroy tumors. The alpha-emitting atoms diffuse only a short distance, allowing Alpha DaRT to primarily affect the tumor while sparing surrounding healthy tissue.
"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 tumor types," said Alpha Tau Chief Executive Officer Uzi Sofer. "We have repeatedly heard the demand from clinicians and patients who want a new, focused alpha-radiation based local salvage therapy for prostate cancer."
Patient recruitment for the pancreatic cancer trial is expected to be completed by the end of Q1 2026, representing a key component of Alpha Tau's broader strategy to bring Alpha DaRT (搜索) to cancer patients with high unmet medical needs.