Prostate CancerNCT07290998
Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Recurrent Prostate Cancer
A study testing Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Prostate Cancer and Recurrent Prostate Cancer, run by Alpha Tau Medical LTD..
Trial summary
This is a multi-center clinical study enrolling up to 12 participants . The primary objective of the study is to evaluate the safety of Alpha DaRT for the treatment of locally recurrent prostate cancer . Read more about this study
- Who is it for?
- Ages 40 to 120 years, men only
- Conditions the study is for
- Prostate Cancer, Recurrent Prostate Cancer, Locally Recurrent Prostate Cancer
- 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
- 12 participants
- Where
- No sites listed yet
- Study dates
- May 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and/or cytologically proven prostate adenocarcinoma
- Biochemical recurrence by the Phoenix definition (PSA nadir + 2 ng/mL) and confirmed by a pre-treatment biopsy.
- Patients eligible for focal salvage brachytherapy
- Clinical stage T1-T2 on relapse; unilateral extracapsular extension (T3a) on MRI permitted except posteriorly relative to the rectum
- Pre-salvage PSA level (rPSA) < 10 ng/ml
- Target lesion is technically amenable for Alpha DaRT sources implantation.
Show all 18Show fewer
- Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 OR by multiparametric MRI according RECIST v1.1 (Patients who were classified as stage II according to MRI)
- Lesion size ≤ 5 cm in the longest diameter
- ECOG Performance Status Scale 0 - 2
- Life expectancy is more than 6 months
- WBC ≥ 3500/µl, granulocyte ≥ 1500/µl
- Platelet count ≥60,000/µl
- Creatinine ≤1.9 mg/dL
- AST and ALT ≤ 2.5 X upper limit of normal (ULN)
- INR < 1.4 for patients not on Warfarin
- Age ≥ 40 years old
- Subjects are willing and able to sign an informed consent form
- Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) for 3 months after DaRT insertion
Who cannot join
- Concomitant immunotherapy within the past 4 weeks.
- Patients with lymph node or metastatic disease
- Known hypersensitivity to any of the components of the treatment.
- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
- Patients with prior surgery or low-dose-rate (LDR) brachytherapy as the primary treatment of their prostate cancer.
- [For Stage 1 of the study only] Patients with prior high-dose-rate (HDR) brachytherapy or stereotactic body radiation therapy (SBRT) as the primary treatment of their prostate cancer.
Show all 13Show fewer
- 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.
- Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.
- Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.
- Patients do not 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 insertion
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Recurrent Prostate Cancer
This is a multi-center clinical study enrolling up to 12 participants . The primary objective of the study is to evaluate the safety of Alpha DaRT for the treatment of locally recurrent prostate cancer . The secondary objectives of the study is to evaluate the efficacy of the Alpha DaRT sources in locally recurrent prostate cancer patients assessed by biochemical and clinical evaluation of disease progression as well as overall survival
Read the detailed description
This study will be a prospective, interventional, open label, single arm, multiple center study to assess the safety efficacy of Alpha DaRT . Eligible patients with Locally Recurrent Prostate Cancer will be categorized into the study.
The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the interstitial intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. DaRT seeds will be inserted into the tumor according to a pre-determined plan.The delivery of the DaRT Sources into the prostate tumor is done by using the Alpha DaRT Alpha Prostate Applicator.
- Being tested
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Keywords
- Alpha radiation, Prostate Cancer, Recurrent Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
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 radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT 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.
Safety -Serious adverse events
The primary safety endpoint is the overall incidence of device related serious adverse events (SAEs) over the duration of the trial
Measured: From Day 0, Up to 3 years
Secondary outcomes (5)
To evaluate the efficacy of DaRT seeds according to blood tests
Biochemical relapse-free survival rate (where relapse is defined according to the Phoenix definition: increase in PSA ≥2 ng/mL above the nadir)
Measured: 12 month study, 2 years follow up ±1 month every 6 months.
To evaluate the efficacy DaRT seeds according to Overall survival
Overall survival
Measured: once every 6 months for 2 years after final follow-up visit at 12 months
To evaluate the efficacy of DaRT seeds according to Life Questionnaire- QLQ- PR25
Quality of life measure by the QLQ-PR25 questionnaire. The score is- 1-Not at all snd 4 is - Very much .
Measured: at day 0, 30 , 12 months and once every 6 months for 2 years
To evaluate the efficacy of DaRT seeds according to Life Questionnaire-IPSS
Quality of life measure by the IPSS- International Prostate Symptom Score. The score is- 1 is not at all and 5 is almost always.
Measured: at day 0, 30 , 12 months and once every 6 months for 2 years
To evaluate the efficacy of DaRT seeds according to Life Questionnaire-SHIM
Quality of life measure by the SHIM - Sexual Health Inventory for Men score, the score is - 1 - very low and 5 is- very high .
Measured: at day 0, 30 , 12 months and once every 6 months for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study startMay 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Alpha Tau Medical LTD.The sponsor's other registered studies.
- 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290998
- Sponsor's protocol ID
- CTP-PRST-05
- Status last verified
- Nov 2025
- First submitted
- 1 Dec 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Recurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT07290998
- Acronym / sponsor ID
- CTP-PRST-05
- Keywords
- Alpha radiation, Prostate Cancer, Recurrent Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 18 Dec 2025 (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.
This is a multi-center clinical study enrolling up to 12 participants . The primary objective of the study is to evaluate the safety of Alpha DaRT for the treatment of locally recurrent prostate cancer . The secondary objectives of the study is to evaluate the efficacy of the Alpha DaRT sources in locally recurrent prostate cancer patients assessed by biochemical and clinical evaluation of disease progression as well as overall survival
Detailed description
This study will be a prospective, interventional, open label, single arm, multiple center study to assess the safety efficacy of Alpha DaRT . Eligible patients with Locally Recurrent Prostate Cancer will be categorized into the study.
The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the interstitial intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. DaRT seeds will be inserted into the tumor according to a pre-determined plan.The delivery of the DaRT Sources into the prostate tumor is done by using the Alpha DaRT Alpha Prostate Applicator.
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
- 40 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically and/or cytologically proven prostate adenocarcinoma
- Biochemical recurrence by the Phoenix definition (PSA nadir + 2 ng/mL) and confirmed by a pre-treatment biopsy.
- Patients eligible for focal salvage brachytherapy
- Clinical stage T1-T2 on relapse; unilateral extracapsular extension (T3a) on MRI permitted except posteriorly relative to the rectum
- Pre-salvage PSA level (rPSA) < 10 ng/ml
Key exclusion criteria (13 listed)
- Concomitant immunotherapy within the past 4 weeks.
- Patients with lymph node or metastatic disease
- Known hypersensitivity to any of the components of the treatment.
- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
- Patients with prior surgery or low-dose-rate (LDR) brachytherapy as the primary treatment of their prostate cancer.
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 radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms | Device | DaRT Seeds |
Primary outcome
Safety -Serious adverse events
Time frame: From Day 0, Up to 3 years
The primary safety endpoint is the overall incidence of device related serious adverse events (SAEs) over the duration of the trial
5 secondary outcomes
To evaluate the efficacy of DaRT seeds according to blood tests
Time frame: 12 month study, 2 years follow up ±1 month every 6 months.
To evaluate the efficacy DaRT seeds according to Overall survival
Time frame: once every 6 months for 2 years after final follow-up visit at 12 months
To evaluate the efficacy of DaRT seeds according to Life Questionnaire- QLQ- PR25
Time frame: at day 0, 30 , 12 months and once every 6 months for 2 years
To evaluate the efficacy of DaRT seeds according to Life Questionnaire-IPSS
Time frame: at day 0, 30 , 12 months and once every 6 months for 2 years
To evaluate the efficacy of DaRT seeds according to Life Questionnaire-SHIM
Time frame: at day 0, 30 , 12 months and once every 6 months for 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Prostate Cancer and Recurrent Prostate Cancer, run by Alpha Tau Medical LTD..
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 18 inclusion and 13 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: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liron Dimnik (0542688602, LironD@alphatau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety -Serious adverse events (time frame: From Day 0, Up to 3 years). 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 6 Apr 2026.