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

NCT06202248 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-02

No results posted yet for this study

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.

Conditions

  • Non-metastatic Prostate Cancer
  • Locally Recurrent Prostate Cancer

Interventions

DEVICE

Experimental: DaRT seeds

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Sponsors & Collaborators

  • Alpha Tau Medical LTD.

    lead INDUSTRY

Principal Investigators

  • Tomer Charas, MD · Radiotherapy unit at Rambam Health Care Campus, Israel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-12
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06202248 on ClinicalTrials.gov