Tiny Alpha-Ray seeds aim to zap recurrent prostate cancer
NCT ID NCT06202248
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new type of radiation seed, called DaRT, can be safely placed inside the prostate to treat cancer that has returned after initial treatment. Up to 10 men with non-metastatic, locally recurrent prostate cancer will receive the seeds. The main goal is to see if the procedure is feasible and safe, and to measure its impact on quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed locally recurrent prostate adenocarcinoma cancer confined to at least 1 hemi-gland with concordant pathology and imaging findings within 6 months prior to consenting * Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 or by multiparametric MRI according RECIST v1.1 * Patient being considered for focal salvage brachytherapy * Lesion size ≤ 3 cm in the longest diameter * Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds * Pre-salvage PSA level (rPSA) below \<10 ng/ml * Age ≥ 18 years old * ECOG Performance Status Scale ≤ 2 * Subjects' life expectancy is more than 6 months * Negative metastatic workup on at least standard imaging (CT CAP and bone scan). Other metastatic screening studies allowed in lieu of standard imaging including multiparametric MRI prostate/whole body, PSMA PET, F18 PET or Axumin PET within 3 months before visit 0 * Platelet count ≥100,000/mm3 * Subjects are willing and able to sign an informed consent form. Exclusion Criteria: * N1 or M1 disease * Prior TURP or prostate surgery * Inability to undergo multiparametric MRI (i.e. permanent implanted device incompatible with MRI) * Inability to undergo general or spinal anesthesia * Prior androgen deprivation therapy or systemic chemotherapy for prostate cancer within 3 months before visit 0. * Previous diagnosis of other malignancy \< 3 years of enrollment (excluding non-melanomatous skin cancer) * 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 * Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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RAMBAM Health Care Campus
RECRUITINGHaifa, 3109601, Israel
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New pill combo aims to shrink tough prostate tumors
- Second chance: focused radiation for recurrent prostate cancer
- New combo treatment targets returned prostate cancer
- Tiny radioactive seeds aim to zap recurrent prostate cancer