NCT06202248

A Study to Assess Alpha DaRT224 for the Treatment of Men With Non-metastatic Locally Recurrent Prostate Cancer

A Feasibility and Safety Study of Focal Interstitial Radiotherapy Using Diffusing Alpha Emitters Radiation Therapy (DaRT) Seeds in Men With Non-metastatic Locally Recurrent Prostate Cancer.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Alpha Tau Medical LTD. · Industry
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center clinical study enrolling up to 10 participants. The purpose of this study is to assess the feasibility and safety of intratumoral DaRT seeds implantation for the treatment of locally recurrent prostate cancer. Secondary objectives are to 1. To evaluate feasibility of interstitial radiotherapy using DaRT seeds. Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging \[Timeframe: immediately following the insertion procedure 2. To assess the impact of DaRT seeds on patient reported quality of life.

Detailed description

This study is a prospective multicenter, single arm, open label , interventional clinical study to assess the feasibility and safety of intratumoral Alpha DaRT seeds for the treatment of men with non metastatic locally recurrent prostate cancer. Diffusing Alpha emitters Radiation Therapy (DaRT). Treatment will be delivered through radioactive sources \[Ra-224 containing Stainless steel 316LVM tubes- (Alpha DaRT seeds)\] inserted into the tumors. The purpose of this study is to assess the feasibility and safety of intratumoral DaRT seeds implantation for the treatment of locally recurrent prostate cancer. The secondary objectives is 1. To evaluate feasibility of interstitial radiotherapy using DaRT seeds. Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging \[Timeframe: immediately following the insertion procedure 2. To assess the impact of DaRT seeds on patient reported quality of life.

Conditions

• Non-metastatic Prostate Cancer
• Locally Recurrent Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Experimental: DaRT seeds	Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Timeline

• Start date: 2024-03-12
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-01-11
• Last updated: 2025-12-02

Locations

1 site across 1 country: Israel