NCT06202248 Alpha Radiation Emitters Device (DaRT) for the Treatment of Non-Metastatic Locally Recurrent Prostate Cancer.
| NCT ID | NCT06202248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alpha Tau Medical LTD. |
| Condition | Non-metastatic Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-03-12 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * N1 or M1 disease * Prior TURP or prostate surgery * Inability to undergo multiparametric MRI (i.e. permanent implanted device incompatible with MRI) * Inability to undergo general or spinal anesthesia * 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) * 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 * 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.)
Contact & Investigator
Tomer Charas, MD
PRINCIPAL INVESTIGATOR
Radiotherapy unit at Rambam Health Care Campus, Israel
Frequently Asked Questions
Who can join the NCT06202248 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 120 Years, studying Non-metastatic Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06202248 currently recruiting?
Yes, NCT06202248 is actively recruiting participants. Contact the research team at LironD@alphatau.com for enrollment information.
Where is the NCT06202248 trial being conducted?
This trial is being conducted at Haifa, Israel.
Who is sponsoring the NCT06202248 clinical trial?
NCT06202248 is sponsored by Alpha Tau Medical LTD.. The principal investigator is Tomer Charas, MD at Radiotherapy unit at Rambam Health Care Campus, Israel. The trial plans to enroll 10 participants.
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