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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.](streamdown:incomplete-link)
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.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DaRT Seeds | Experimental | Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: DaRT seeds | Device | Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of intratumoral DaRT seeds implantation | 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 | immediately following the insertion procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liron Dimnik | Contact | +972542688602 | LironD@alphatau.com | |
| Aviya Hoida | Contact | +972547869466 | aviyah@alphatau.com |
| Name | Affiliation | Role |
|---|---|---|
| Tomer Charas, MD | Radiotherapy unit at Rambam Health Care Campus, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RAMBAM Health Care Campus | Recruiting | Haifa | 3109601 | Israel |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |