Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06202248
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-12-31
Brief Title:
A Study to Assess Alpha DaRT224 for the Treatment of Men With Non-metastatic Locally Recurrent Prostate Cancer
Sponsor:
Alpha Tau Medical LTD
Organization:
Alpha Tau Medical LTD
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None