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

NCT06202248 | Recruiting

• 1 other identifier: CTP-PRST-00
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-metastatic Prostate Cancer; Locally Recurrent Prostate Cancer

Keywords

recurrent prostate cancer.; Alpha emitting radiation; Alpha DaRT; Prostate cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of intratumoral DaRT seeds implantation

  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

  immediately following the insertion procedure

Study Arms (1)

DaRT Seeds

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Device: Experimental: DaRT seeds

Interventions

Experimental: DaRT seeds DEVICE

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

DaRT Seeds

Eligibility Criteria

• Age: 18 Years - 120 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (1)

RAMBAM Health Care Campus

Haifa, 3109601, Israel

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Tomer Charas, MD

  Radiotherapy unit at Rambam Health Care Campus, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liron Dimnik

CONTACT

+972542688602; LironD@alphatau.com

Aviya Hoida

CONTACT

+972547869466; aviyah@alphatau.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2023
• First Posted: January 11, 2024
• Study Start: March 12, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)