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

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ClinicalTrials.gov Identifier: NCT04543903
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : July 6, 2022
Sponsor:
Information provided by (Responsible Party):
Alpha Tau Medical LTD.

Study Description
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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

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) Not Applicable

Detailed Description:

The study is planned as a prospective, open-label, one arm, single center trial, designed to assess the feasibility and safety of intratumoral DaRT seeds implantation for the treatment of local prostate cancer prior to surgery.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Prostate lesions with histopathological confirmation of adenocarcinoma will be treated using DaRT seeds in a neo-adjuvant setting.

Feasibility will be assessed by the successful delivery of DaRT seeds into the intratumoral environment. In addition, objective response rate will be assessed both by imaging and pathology.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility of Neoadjuvant Interstitial Brachytherapy (Ibt) Using Diffusing Alpha Emitters Radiation Therapy (Dart) Seeds in Men With Prostate Cancer
Actual Study Start Date : May 16, 2022
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
 Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
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.


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of intratumoral DaRT seeds implantation [ Time Frame: Study visit 'Day 0' ]
    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.

  2. Safety of intratumoral DaRT seeds implantation [ Time Frame: Study visit 'Day 0' ]

    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.



Secondary Outcome Measures :
  1. Pathological ORR [ Time Frame: Week 4-6 ]
    To asses the percentage of patients whose cancer shrinks or disappears after treatment using a biopsy from removed prostate.

  2. Radiological ORR [ Time Frame: 1 Week prior to surgery ]
    Radiological response rate according to PSMA-PET/ multiparametric MRI (SUV change/T2 weighting) through comparison with baseline imaging as assessed by RECIST or PERCIST.

  3. Change in quality of life [ Time Frame: Screening. Day 22. ]
    Change in disease related QoL using the EPIC questionnaires from baseline to prior to surgery

  4. Change in quality of life [ Time Frame: Screening. Day 22. ]
    Change in disease related QoL using the IPSS questionnaires from baseline to prior to surgery


Other Outcome Measures:
  1. Assess DNA damage and repair [ Time Frame: Day 40 - 60 ]
    Assess DNA damage and repair (biomarker analysis: γH2AX foci, TUNEL, RAD51, RAD50, BRCA1, XRCC2, XRCC6) from baseline to surgery following DaRT seeds insertion.

  2. Assess immune infiltration [ Time Frame: Day 40 - 60 ]
    Assess immune cell infiltration (biomarker analysis: CD34, TILs) from baseline to surgery following DaRT seeds insertion.

  3. Biochemical response evaluation [ Time Frame: Day 19-25, Day 68-82 ]
    Biochemical response evaluation based on PSA levels


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543903


Contacts
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Contact: Ester Deutsch +972-2-3737-212 EsterD@alphatau.com
Contact: Liron Dimnik +972-2-3737-210 LironD@alphatau.com

Locations
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Israel
RAMBAM Health Care Campus Recruiting
Haifa, Israel, 3109601
Contact: Tomer Charas, MD    +972-4-777-6505    t_charas@rmc.gov.il   
Principal Investigator: Tomer Charas, MD         
Carmel Medical Center Recruiting
Haifa, Israel, 3436212
Contact: Yuval Freifeld, MD    +972-523453511    yuvalfrei@gmail.com   
Sponsors and Collaborators
Alpha Tau Medical LTD.
Investigators
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Principal Investigator: Tomer Charas, M.D Radiotherapy unit at Rambam Health Care Campus, Israel
More Information
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Responsible Party: Alpha Tau Medical LTD.
ClinicalTrials.gov Identifier: NCT04543903    
Other Study ID Numbers: CTP-PRST-02
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alpha Tau Medical LTD.:
Prostate adenocarcinoma
Alpha radiation
Brachytherapy
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type