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

Primary Purpose

Prostate Adenocarcinoma

Status

Recruiting

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring Prostate adenocarcinoma, Alpha radiation, Brachytherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

RAMBAM Health Care CampusRecruiting
Carmel Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DaRT Seeds

Arm Description

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Pathological ORR

To asses the percentage of patients whose cancer shrinks or disappears after treatment using a biopsy from removed prostate.

Radiological ORR

Radiological response rate according to PSMA-PET/ multiparametric MRI (SUV change/T2 weighting) through comparison with baseline imaging as assessed by RECIST or PERCIST.

Change in quality of life

Change in disease related QoL using the EPIC questionnaires from baseline to prior to surgery

Change in quality of life

Change in disease related QoL using the IPSS questionnaires from baseline to prior to surgery

Full Information

NCT ID

NCT04543903

First Posted

August 30, 2020

Last Updated

July 23, 2023

Sponsor

Alpha Tau Medical LTD.

1. Study Identification

Unique Protocol Identification Number

NCT04543903

Brief Title

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

Official Title

A Feasibility of Neoadjuvant Interstitial Brachytherapy (Ibt) Using Diffusing Alpha Emitters Radiation Therapy (Dart) Seeds in Men With Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 16, 2022 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alpha Tau Medical LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Adenocarcinoma

Keywords

Prostate adenocarcinoma, Alpha radiation, Brachytherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DaRT Seeds

Arm Type

Experimental

Arm Description

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Intervention Type

Device

Intervention Name(s)

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Feasibility of intratumoral DaRT seeds implantation

Description

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.

Time Frame

Study visit 'Day 0'

Title

Safety of intratumoral DaRT seeds implantation

Description

Time Frame

Study visit 'Day 0'

Secondary Outcome Measure Information:

Title

Pathological ORR

Description

To asses the percentage of patients whose cancer shrinks or disappears after treatment using a biopsy from removed prostate.

Time Frame

Week 4-6

Title

Radiological ORR

Description

Radiological response rate according to PSMA-PET/ multiparametric MRI (SUV change/T2 weighting) through comparison with baseline imaging as assessed by RECIST or PERCIST.

Time Frame

1 Week prior to surgery

Title

Change in quality of life

Description

Change in disease related QoL using the EPIC questionnaires from baseline to prior to surgery

Time Frame

Screening. Day 22.

Title

Change in quality of life

Description

Change in disease related QoL using the IPSS questionnaires from baseline to prior to surgery

Time Frame

Screening. Day 22.

Other Pre-specified Outcome Measures:

Title

Assess DNA damage and repair

Description

Assess DNA damage and repair (biomarker analysis: γH2AX foci, TUNEL, RAD51, RAD50, BRCA1, XRCC2, XRCC6) from baseline to surgery following DaRT seeds insertion.

Time Frame

Day 40 - 60

Title

Assess immune infiltration

Description

Assess immune cell infiltration (biomarker analysis: CD34, TILs) from baseline to surgery following DaRT seeds insertion.

Time Frame

Day 40 - 60

Title

Biochemical response evaluation

Description

Biochemical response evaluation based on PSA levels

Time Frame

Day 19-25, Day 68-82

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ester Deutsch

Phone

+972-2-3737-212

EsterD@alphatau.com

First Name & Middle Initial & Last Name or Official Title & Degree

Liron Dimnik

Phone

+972-2-3737-210

LironD@alphatau.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tomer Charas, M.D

Organizational Affiliation

Radiotherapy unit at Rambam Health Care Campus, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

RAMBAM Health Care Campus

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tomer Charas, MD

Phone

+972-4-777-6505

t_charas@rmc.gov.il

First Name & Middle Initial & Last Name & Degree

Tomer Charas, MD

Facility Name

Carmel Medical Center

City

Haifa

ZIP/Postal Code

3436212

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuval Freifeld, MD

Phone

+972-523453511

yuvalfrei@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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