Clinical trial · Interventional
Neoadjuvant Interstitial Brachytherapy Using Diffusing Alpha Emitters Radiation Therapy in Men With Prostate Cancer
A Feasibility of Neoadjuvant Interstitial Brachytherapy (Ibt) Using Diffusing Alpha Emitters Radiation Therapy (Dart) Seeds in Men With Prostate Cancer
NCT04543903CI-TRIAL-00098237completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device as a neo-adjuvant therapy in men with prostate cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DaRT Seeds
- description
- Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
- interventionNames
- Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Primary outcomes (2)
- measure
- Feasibility of intratumoral DaRT seeds implantation
- timeFrame
- Study visit 'Day 0'
- description
- 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.
- measure
- Safety of intratumoral DaRT seeds implantation
- timeFrame
- Study visit 'Day 0'
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.