NCT04543903

Neoadjuvant Interstitial Brachytherapy Using Diffusing Alpha Emitters Radiation Therapy in Men With Prostate Cancer

A Feasibility of Neoadjuvant Interstitial Brachytherapy (Ibt) Using Diffusing Alpha Emitters Radiation Therapy (Dart) Seeds in Men With Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Alpha Tau Medical LTD. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device as a neo-adjuvant therapy in men with prostate cancer

Detailed description

The study is planned as a prospective, open-label, one arm, single center trial, designed to assess the feasibility and safety of intratumoral DaRT seeds implantation for the treatment of local prostate cancer prior to surgery. This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients. Prostate lesions with histopathological confirmation of adenocarcinoma will be treated using DaRT seeds in a neo-adjuvant setting. Feasibility will be assessed by the successful delivery of DaRT seeds into the intratumoral environment. In addition, objective response rate will be assessed both by imaging and pathology.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DEVICE	Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)	An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.

Timeline

• Start date: 2022-05-16
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2020-09-10
• Last updated: 2025-12-02

Locations

3 sites across 1 country: Israel