FDA gives nod to trial of alpha-radiation therapy for prostate cancer

The FDA has approved an investigational drug exemption (IDE) application to initiate a pilot study of Alpha DaRT, an alpha-radiation therapy for patients with locally recurrent prostate cancer, Alpha Tau Medical announced in a news release.¹

According to the company, Alpha DaRT is “designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources.” Since alpha particles can only diffuse over a short distance, Alpha DaRT is expected to be able to treat the tumor while preserving the surrounding healthy tissue.

The agent is currently under investigation across a range of malignancies, including glioblastoma, squamous cell carcinoma, and pancreatic cancer, among others.²

“With this IDE approval, our fifth in the US currently active, Alpha Tau continues to broaden its reach in the US across a range of tumor types,” said Uzi Sofer, CEO of Alpha Tau Medical, in the news relase.¹ “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 [we] are eager to explore the benefits that Alpha DaRT may bring to recurrent prostate cancer patients, who currently face a number of poor available alternatives.”

In total, the trial plans to enroll up to 12 patients across clinical trial sites in the US. Patients enrolled in the study must have locally recurrent prostate cancer with biochemical recurrence per the Phoenix definition (a rise of prostate-specific antigen [PSA] levels by 2 ng/mL from the PSA nadir).

The primary end point of the study is safety. Secondary end points include biochemical and clinical evaluation of disease progression as well as overall survival.

The current study is expected to build on what the company deemed promising results from trials (NCT04543903; NCT06202248) of Alpha DaRT therapy conducted in Israel.

“We are excited to bring the Alpha DaRT technology to prostate cancer patients in the US,” said Robert B. Den, MD, Chief Medical Officer of Alpha Tau and associate professor of radiation oncology, cancer biology, and urology at Thomas Jefferson University, in the news release.¹ “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.”

REFERENCES

1. Alpha Tau receives FDA approval to initiate a trial for patients with locally recurrent prostate cancer. News release. Alpha Tau Medical Ltd. December 2, 2025. Accessed December 9, 2025. https://www.alphatau.com/single-post/alpha-tau-receives-fda-approval-to-initiate-a-trial-for-patients-with-locally-recurrent-prostate-can

2. Alpha DaRT clinical trials. Alpha Tau Medical. Accessed December 9, 2025. https://www.alphatau.com/alpha-dart-clinical-trials