Tiny radioactive seeds tested against prostate cancer
NCT ID NCT04543903
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new type of radiation therapy called DaRT seeds for men with prostate cancer. The goal was to see if it is safe and possible to place these tiny radioactive seeds directly into the tumor before surgery. Only one person took part, and the focus was on whether the procedure could be done without major problems.
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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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1 person
The number who actually took part.
- Started
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May 2022
- Finished
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Oct 2025
- 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 years and older
- 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: * 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
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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.
Contacts and locations
Locations
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Carmel Medical Center
Haifa, 3436212, Israel
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RAMBAM Health Care Campus
Haifa, 3109601, Israel
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Tel Aviv Medical Center
Tel Aviv, Israel
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Can a One-Two radiation punch improve prostate cancer control?
- Can a special PET scan change the course of prostate cancer?
- Can a High-Tech radiation beam hit prostate tumors without harming healthy tissue?
- Can 3D imaging make prostate radiation more precise and worth the cost?
- Can surgery boost control of spread prostate cancer?