Alpha Radiation Emitters Device (DaRT) for the Treatment of Non-Metastatic Locally Recurrent Prostate Cancer.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-120
SponsorAlpha Tau Medical LTD.
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Experimental: DaRT seeds
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov