A Study to Assess Alpha DaRT224 for the Treatment of Men With Non-metastatic Locally Recurrent Prostate Cancer

Launched by ALPHA TAU MEDICAL LTD. · Dec 31, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Alpha DaRT224 for men with non-metastatic locally recurrent prostate cancer. The study aims to see if placing tiny seeds, known as DaRT seeds, inside the tumor can be done safely and if it helps improve patients' quality of life. Up to 10 men will participate, and the researchers will check how well the seeds can be placed using imaging techniques like MRI or PET scans.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of locally recurrent prostate cancer that is not spreading. They should have a tumor that is 3 cm or smaller and can be treated with the DaRT seeds. Participants will be closely monitored during the study, and they will need to provide informed consent, meaning they agree to take part after understanding the details. It's important to note that men with certain health conditions or previous treatments may not be able to join. Overall, this trial aims to explore a promising new option for treating this type of prostate cancer.

Gender

MALE

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.)