RecruitingNot ApplicableNCT06202248

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.


Sponsor

Alpha Tau Medical LTD.

Enrollment

10 participants

Start Date

Mar 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a targeted radiation therapy called Alpha DaRT, using radioactive seeds placed directly into the tumor, for men whose prostate cancer has returned in the same location after previous treatment (called local recurrence). **You may be eligible if...** - You are a man aged 18 or older with prostate cancer that has come back locally after prior treatment - The recurrence is confirmed by biopsy, MRI, or PSMA PET scan - The tumor is 3 cm or smaller - Your PSA level is below 10 ng/mL - Your cancer has not spread to other parts of the body - You are being considered for a focal (targeted) salvage treatment **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or distant organs - You previously had TURP (a surgical procedure for the prostate) or prostate surgery - You cannot have an MRI or cannot undergo anesthesia - You have had hormone therapy or chemotherapy for prostate cancer in the last 3 months - You have been diagnosed with another cancer in the last 3 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExperimental: DaRT seeds

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds


Locations(1)

RAMBAM Health Care Campus

Haifa, Israel

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NCT06202248


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