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

NCT07290998 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-04-06

No results posted yet for this study

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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Alpha Tau Medical LTD.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-05-31
Completion
2029-05-31
FDA Device
Yes

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Entities

Diseases

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 NCT07290998 on ClinicalTrials.gov