Tests DaRT alpha radiation seeds for prostate cancer that has returned locally
Tests small radiation seeds placed inside the tumor in men with returned prostate cancer.
Plain-language title generated from the registry record
Registry title: Alpha Radiation Emitters Device (DaRT) for the Treatment of Non-Metastatic Locally Recurrent Prostate Cancer.
Key facts
- Where
- Haifa, IsraelSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 120 years old?
Source: NCT06202248, who can take part
Where in Israel
- Rambam Health Care CampusHaifa, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alpha Tau Medical LTD.
- Trial code
- NCT06202248
- Record updated
- 16 June 2026
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: Histologically confirmed locally recurrent prostate adenocarcinoma cancer confined to at least 1 hemi-gland with concordant pathology and imaging findings within 6 months prior to consenting; Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 or by multiparametric MRI according RECIST v1.1; Patient being considered for focal salvage brachytherapy; Lesion size ≤ 3 cm in the longest diameter; Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds; Pre-salvage PSA level (rPSA) below <10 ng/ml; Age ≥ 18 years old; ECOG Performance Status Scale ≤ 2; Subjects' life expectancy is more than 6 months; Negative metastatic workup on at least standard imaging (CT CAP and bone scan). Other metastatic screening studies allowed in lieu of standard imaging including multiparametric MRI prostate/whole body, PSMA PET, F18 PET or Axumin PET within 3 months before visit 0; Platelet count ≥100,000/mm3; Subjects are willing and able to sign an informed consent form.
Exclusion: Prior TURP or prostate surgery; Prior androgen deprivation therapy or systemic chemotherapy for prostate cancer within 3 months before visit 0; Previous diagnosis of other malignancy < 3 years of enrollment (excluding non-melanomatous skin cancer); N1 or M1 disease; Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.); Inability to undergo multiparametric MRI (i.e. permanent implanted device incompatible with MRI); Inability to undergo general or spinal anesthesia; Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT; High probability of protocol non-compliance (in opinion of investigator); Subjects not willing to sign an informed consent.