Loading clinical trials...
Loading clinical trials...
A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Recurrent Prostate Cancer
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
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.
Age
40 - 120 years
Sex
MALE
Healthy Volunteers
No
Start Date
May 1, 2026
Primary Completion Date
May 1, 2028
Completion Date
May 1, 2029
Last Updated
December 18, 2025
12
ESTIMATED participants
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
DEVICE
Lead Sponsor
Alpha Tau Medical LTD.
NCT04550494
NCT05691465
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions