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

Alpha Tau Medical

Status

Enrolling

Conditions

Locally Recurrent Prostate Cancer

Non-metastatic Prostate Cancer

Treatments

Device: Experimental: DaRT seeds

Study type

Interventional

Funder types

Industry

Identifiers

NCT06202248

CTP-PRST-00

Details and patient eligibility

About

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.

Full description

This study is a prospective multicenter, single arm, open label , interventional clinical study to assess the feasibility and safety of intratumoral Alpha DaRT seeds for the treatment of men with non metastatic locally recurrent prostate cancer.

Diffusing Alpha emitters Radiation Therapy (DaRT). Treatment will be delivered through radioactive sources [Ra-224 containing Stainless steel 316LVM tubes- (Alpha DaRT seeds)] inserted into the tumors.

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. The secondary objectives is 1. To evaluate feasibility of interstitial radiotherapy using DaRT seeds.

Enrollment

10 estimated patients

Sex

Male

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

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.)