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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
DeviceAn intratumoral insertion of radioactive sources \[Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)\]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: DaRT SeedsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety -Serious adverse events
The primary safety endpoint is the overall incidence of device related serious adverse events (SAEs) over the duration of the trial
Time frame
From Day 0, Up to 3 yearsSecondary outcomes
1
To evaluate the efficacy of DaRT seeds according to blood tests
Biochemical relapse-free survival rate (where relapse is defined according to the Phoenix definition: increase in PSA ≥2 ng/mL above the nadir)
Time frame
12 month study, 2 years follow up ±1 month every 6 months.2
To evaluate the efficacy DaRT seeds according to Overall survival
Overall survival
Time frame
once every 6 months for 2 years after final follow-up visit at 12 months3
To evaluate the efficacy of DaRT seeds according to Life Questionnaire- QLQ- PR25
Quality of life measure by the QLQ-PR25 questionnaire. The score is- 1-Not at all snd 4 is - Very much .
Time frame
at day 0, 30 , 12 months and once every 6 months for 2 years4
To evaluate the efficacy of DaRT seeds according to Life Questionnaire-IPSS
Quality of life measure by the IPSS- International Prostate Symptom Score. The score is- 1 is not at all and 5 is almost always.
Time frame
at day 0, 30 , 12 months and once every 6 months for 2 yearsOther outcomes
1
To evaluate the efficacy of DaRT seeds according to clinical evaluation measured by Physical Examination and ECOG Performance status.
The secondary objective of the study is to evaluate the efficacy of the Alpha DaRT sources in locally recurrent prostate cancer patients assessed by clinical evaluation of the physician assessment and Performance status score cale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis, the score is from- 1- fully active and 5- Dead.
Time frame
up to 3 years2
To evaluate the efficacy of DaRT seeds according to Disease progression measured by MRI / PSMA PET
The secondary objective of the study is to evaluate the efficacy of the Alpha DaRT sources in locally recurrent prostate cancer patients assessed by Disease progression .
Time frame
Up to 3 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: