NCT07290998

Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Recurrent Prostate Cancer

A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Recurrent Prostate Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Alpha Tau Medical LTD. · Industry
• Sex: Male
• Age: 40 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center clinical study enrolling up to 12 participants . The primary objective of the study is to evaluate the safety of Alpha DaRT for the treatment of locally recurrent prostate cancer . The secondary objectives of the study is to evaluate the efficacy of the Alpha DaRT sources in locally recurrent prostate cancer patients assessed by biochemical and clinical evaluation of disease progression as well as overall survival

Detailed description

This study will be a prospective, interventional, open label, single arm, multiple center study to assess the safety efficacy of Alpha DaRT . Eligible patients with Locally Recurrent Prostate Cancer will be categorized into the study. The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the interstitial intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. DaRT seeds will be inserted into the tumor according to a pre-determined plan.The delivery of the DaRT Sources into the prostate tumor is done by using the Alpha DaRT Alpha Prostate Applicator.

Conditions

• Prostate Cancer
• Recurrent Prostate Cancer
• Locally Recurrent Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)	An intratumoral insertion of radioactive sources \[Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)\]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-05-01
• Completion: 2029-05-01
• First posted: 2025-12-18
• Last updated: 2026-04-06

Regulatory

• FDA-regulated device study