Prostate AdenocarcinomaNCT04543903
Neoadjuvant Interstitial Brachytherapy Using Diffusing Alpha Emitters Radiation Therapy in Men With Prostate Cancer
A study testing Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Prostate Adenocarcinoma, run by Alpha Tau Medical LTD. at 3 sites in Israel.
Trial summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device as a neo-adjuvant therapy in men with prostate cancer Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 3 sitesIsrael
- Study dates
- 16 May 2022to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
RAMBAM Health Care Campus
Haifa, 3109601
Carmel Medical Center
Haifa, 3436212
Tel Aviv Medical Center
Tel Aviv
About this study
Official title: A Feasibility of Neoadjuvant Interstitial Brachytherapy (Ibt) Using Diffusing Alpha Emitters Radiation Therapy (Dart) Seeds in Men With Prostate Cancer
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device as a neo-adjuvant therapy in men with prostate cancer
Read the 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.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Keywords
- Prostate adenocarcinoma, Alpha radiation, Brachytherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| DaRT Seeds | Experimental | Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds Receives: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Study visit 'Day 0'
Secondary outcomes (4)
Pathological ORR
To asses the percentage of patients whose cancer shrinks or disappears after treatment using a biopsy from removed prostate.
Measured: Week 4-6
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.
Measured: 1 Week prior to surgery
Change in quality of life
Change in disease related QoL using the EPIC questionnaires from baseline to prior to surgery
Measured: Screening. Day 22.
Change in quality of life
Change in disease related QoL using the IPSS questionnaires from baseline to prior to surgery
Measured: Screening. Day 22.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start16 May 2022
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomer Charas, M.D, Principal investigator, Radiotherapy unit at Rambam Health Care Campus, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543903
- Sponsor's protocol ID
- CTP-PRST-02
- Status last verified
- Nov 2024
- First submitted
- 30 Aug 2020
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility of Neoadjuvant Interstitial Brachytherapy (Ibt) Using Diffusing Alpha Emitters Radiation Therapy (Dart) Seeds in Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT04543903
- Acronym / sponsor ID
- CTP-PRST-02
- Conditions
- Prostate Adenocarcinoma
- Keywords
- Prostate adenocarcinoma, Alpha radiation, Brachytherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DaRT Seeds | Experimental | Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | DaRT Seeds |
Primary outcome
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.
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.
4 secondary outcomes
Pathological ORR
Time frame: Week 4-6
Radiological ORR
Time frame: 1 Week prior to surgery
Change in quality of life
Time frame: Screening. Day 22.
Change in quality of life
Time frame: Screening. Day 22.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomer Charas, M.D principal investigator
Radiotherapy unit at Rambam Health Care Campus, Israel
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Prostate Adenocarcinoma, run by Alpha Tau Medical LTD. at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intratumoral DaRT seeds implantation (time frame: Study visit 'Day 0'). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.