Neoadjuvant Interstitial Brachytherapy Using Diffusing Alpha Emitters Radiation Therapy in Men With Prostate Cancer

Prior treatment

• Prior TURP or prostate surgery
• Prior pelvic radiation
• Any prior pelvic malignancy or other malignancy in the last 5 years, except for cured non-melanoma skin cancer
• Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT implant procedure

Other illness

• Known hypersensitivity to any of the components of the treatment.
• Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
• Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.

Other

• Documented evidence of distant metastases
• Inability to undergo MRI (i.e. permanent implanted device incompatible with MRI)
• 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

• Pathologically confirmed, previously untreated, resectable prostate adenocarcinoma
• Ability to provide tissue sample from the target or its vicinity, either from an archive or undergo another biopsy to provide a fresh sample
• Medically fit for surgery
• Targetable lesion must be technically amenable for complete coverage (including 3-5mm margins) by the DaRT seeds
• Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 OR by multiparametric MRI according RECIST v1.1
• Patients must be willing to undergo imaging before and after treatment with DaRT (prior to surgery)
• Lesion size ≤ 3 cm in the longest diameter
• Age ≥ 18 years old
• ECOG Performance Status Scale ≤ 1
• Subjects' life expectancy is more than 6 months
• WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
• Platelet count ≥ 100,000/μl
• Calculated or measured creatinine clearance ≥ 60 cc/min
• AST and ALT ≤ 2.5 X ULN
• INR \<1.4 for patients not on Warfarin
• Subjects are willing and able to sign an informed consent form