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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
This study will be a prospective, interventional, open label, single arm, multiple center study to assess the safety efficacy of Alpha DaRT . Eligible patients with Locally Recurrent Prostate Cancer will be categorized into the study.
The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the interstitial intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. DaRT seeds will be inserted into the tumor according to a pre-determined plan.The delivery of the DaRT Sources into the prostate tumor is done by using the Alpha DaRT Alpha Prostate Applicator.
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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 |
|---|---|---|---|---|
| Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety -Serious adverse events | The primary safety endpoint is the overall incidence of device related serious adverse events (SAEs) over the duration of the trial | From Day 0, Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of DaRT seeds according to blood tests | Biochemical relapse-free survival rate (where relapse is defined according to the Phoenix definition: increase in PSA ≥2 ng/mL above the nadir) | 12 month study, 2 years follow up ±1 month every 6 months. |
| To evaluate the efficacy DaRT seeds according to Overall survival |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of DaRT seeds according to clinical evaluation measured by Physical Examination and ECOG Performance status. | The secondary objective of the study is to evaluate the efficacy of the Alpha DaRT sources in locally recurrent prostate cancer patients assessed by clinical evaluation of the physician assessment and Performance status score cale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis, the score is from- 1- fully active and 5- Dead. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liron Dimnik | Contact | 0542688602 | LironD@alphatau.com | |
| Aviya Hoida | Contact | 972-547869466 | aviyah@alphatau.com |
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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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Overall survival |
| once every 6 months for 2 years after final follow-up visit at 12 months |
| To evaluate the efficacy of DaRT seeds according to Life Questionnaire- QLQ- PR25 | Quality of life measure by the QLQ-PR25 questionnaire. The score is- 1-Not at all snd 4 is - Very much . | at day 0, 30 , 12 months and once every 6 months for 2 years |
| To evaluate the efficacy of DaRT seeds according to Life Questionnaire-IPSS | Quality of life measure by the IPSS- International Prostate Symptom Score. The score is- 1 is not at all and 5 is almost always. | at day 0, 30 , 12 months and once every 6 months for 2 years |
| To evaluate the efficacy of DaRT seeds according to Life Questionnaire-SHIM | Quality of life measure by the SHIM - Sexual Health Inventory for Men score, the score is - 1 - very low and 5 is- very high . | at day 0, 30 , 12 months and once every 6 months for 2 years |
| up to 3 years |
| To evaluate the efficacy of DaRT seeds according to Disease progression measured by MRI / PSMA PET | The secondary objective of the study is to evaluate the efficacy of the Alpha DaRT sources in locally recurrent prostate cancer patients assessed by Disease progression . | Up to 3 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |