Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Recurrent Prostate Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-120
SponsorAlpha Tau Medical LTD.
About this trial
This is a multi-center clinical study enrolling up to 12 participants . The primary objective of the study is to evaluate the safety of Alpha DaRT for the treatment of locally recurrent prostate cancer . The secondary objectives of the study is to evaluate the efficacy of the Alpha DaRT sources in locally recurrent prostate cancer patients assessed by biochemical and clinical evaluation of disease progression as well as overall survival
Eligibility criteria
Qualifiers
Histologically and/or cytologically proven prostate adenocarcinoma
Biochemical recurrence by the Phoenix definition (PSA nadir + 2 ng/mL) and confirmed by a pre-treatment biopsy.
Patients eligible for focal salvage brachytherapy
Clinical stage T1-T2 on relapse; unilateral extracapsular extension (T3a) on MRI permitted except posteriorly relative to the rectum
Disqualifiers
Concomitant immunotherapy within the past 4 weeks.
Patients with lymph node or metastatic disease
Known hypersensitivity to any of the components of the treatment.
Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
Trial design
Treatments tested in this trial
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Treatment groups
12 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov