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

NCT04543903 | Completed

• 1 other identifier: CTP-PRST-02
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

Brief Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device as a neo-adjuvant therapy in men with prostate cancer

Conditions

Prostate Adenocarcinoma

Keywords

Prostate adenocarcinoma; Alpha radiation; Brachytherapy

Outcome Measures

Primary Outcomes (2)

• Feasibility of intratumoral DaRT seeds implantation

  To evaluate the feasibility of intratumoral insertion of DaRT seeds into prostate adenocarcinoma in the neoadjuvant setting. Feasibility will defined as the successful delivery of DaRT.

  Study visit 'Day 0'

• Safety of intratumoral DaRT seeds implantation

  To evaluate the safety of intratumoral insertion of DaRT seeds into prostate adenocarcinoma in the neoadjuvant setting. To evaluate the safety of intratumoral insertion of DaRT seeds into prostate adenocarcinoma in the neoadjuvant setting by the frequency and severity of acute adverse events related to DaRT. Adverse events will be assessed and graded according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.

  Study visit 'Day 0'

Secondary Outcomes (4)

• Pathological ORR

  Week 4-6

• Radiological ORR

  1 Week prior to surgery

• Change in quality of life

  Screening. Day 22.

• Change in quality of life

  Screening. Day 22.

Other Outcomes (3)

• Assess DNA damage and repair

  Day 40 - 60

• Assess immune infiltration

  Day 40 - 60

• Biochemical response evaluation

  Day 19-25, Day 68-82

Study Arms (1)

DaRT Seeds

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Interventions

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) DEVICE

An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.

DaRT Seeds

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (3)

RAMBAM Health Care Campus

Haifa, 3109601, Israel

Location

Carmel Medical Center

Haifa, 3436212, Israel

Location

Tel Aviv Medical Center

Tel Aviv, Israel

Location

Study Officials

• Tomer Charas, M.D

  Radiotherapy unit at Rambam Health Care Campus, Israel

  PRINCIPAL INVESTIGATOR

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: August 30, 2020
• First Posted: September 10, 2020
• Study Start: May 16, 2022
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 2, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3)