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Tiny radioactive seeds tested against prostate cancer

NCT ID NCT04543903

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

1 person

The number who actually took part.

Started

May 2022

Finished

Oct 2025

Lead sponsor

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

18 years and older

Sex

Male participants only

Healthy volunteers

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

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

  • Carmel Medical Center

    Haifa, 3436212, Israel

  • RAMBAM Health Care Campus

    Haifa, 3109601, Israel

  • Tel Aviv Medical Center

    Tel Aviv, Israel

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