NCT06202248Recruiting
Alpha Radiation Emitters Device (DaRT) for the Treatment of 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.
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 31 Dec 2023
- Start date
- 12 Mar 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Alpha Tau Medical LTD.
- Diseases
- Prostate cancer
- NCT number
- NCT06202248
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 12 Mar 2024 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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.)
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 120 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.