Alpha Tau Expands Alpha DaRT Into Recurrent Prostate Cancer: What Investors Should Watch

Alpha Tau Medical Ltd (DRTS) announced an update on their ongoing clinical study.

Study Overview – Alpha Tau Medical Ltd. (NASDAQ: DRTS) is launching a new safety study titled “A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Recurrent Prostate Cancer.” The trial will enroll up to 12 men whose prostate cancer has come back after earlier treatment. The main goal is to check how safe Alpha Tau’s Alpha DaRT technology is in this setting, with a secondary look at how well it controls the disease and supports survival. For investors, this is an early but important step in testing the platform in a large and common cancer market.

Intervention/Treatment – The study tests a device-based treatment called Diffusing Alpha Radiation Emitters Therapy (Alpha DaRT). Tiny radioactive “seeds” made from stainless-steel tubes are placed directly into the tumor. These seeds release short‑lived alpha‑emitting atoms designed to damage cancer cells in the targeted area while aiming to limit impact on healthy tissue. The goal is to offer a local option for men whose prostate cancer has returned.

Study Design – This is an interventional, single‑arm study, meaning all patients receive the same Alpha DaRT treatment and there is no comparison group. There is no random assignment and no masking; both doctors and patients know what therapy is being given. The trial is treatment‑focused, with safety as the main measure, supported by tracking cancer control and disease progression over time.

Study Timeline – The trial status is “Not Yet Recruiting,” so patient enrollment has not started. The study was first submitted on December 1, 2025, signaling a recent move to expand Alpha DaRT into recurrent prostate cancer. The latest update was filed on December 17, 2025, which shows the protocol is active and being maintained. Primary completion and final completion dates have not yet been posted, which is typical at this early stage.

Market Implications – For Alpha Tau, this new trial broadens its clinical pipeline beyond head and neck and other solid tumors into prostate cancer, one of the largest oncology markets. A positive safety profile in even a small group could support the platform story and help justify ongoing development costs, which may improve sentiment among long‑term holders. However, the early‑stage nature, tiny sample size, and lack of efficacy endpoints as primary outcomes mean near‑term revenue impact is limited. Competitors in prostate cancer—such as companies developing targeted radioligand therapies and advanced radiation platforms—are already active, so Alpha Tau’s value will depend on showing a clear safety and convenience edge. Investors should see this as an optionality enhancer rather than a near‑term catalyst and watch for future enrollment and early safety readouts.

The study is currently listed as ongoing in setup, with the most recent information available on the ClinicalTrials.gov portal.