Clinical trial · Interventional
Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound
Phase II Study of Dynamic Intraoperative Dosimetry for Prostate Brachytherapy Using Registered Fluoroscopy and Ultrasound
NCT02225925CI-TRIAL-00064646completedN/AResults postedClinicalTrials.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)
The purpose of this study is to assess the performance of a system of intraoperative dynamic dosimetry during prostate seed implantation (brachytherapy) including its new elements, to evaluate and refine technical methods of using the system, as well as confirm its performance and accuracy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dynamic dosimetry brachytherapy
- description
- Cohort treated with dynamic dosimetry brachytherapy
- interventionNames
- Radiation: Brachytherapy
Primary outcomes (1)
- measure
- Procedure Time
- timeFrame
- at time of implantation procedure
- description
- Additional procedure time with the registered ultrasound and fluoroscopy system (RUF) in the intra-operative setting for implantation procedure
Secondary outcomes (7)
- measure
- Seed Reconstruction From Intra-operative Fluoroscopy
- timeFrame
- up to 30 days post-treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, localized adenocarcinoma of the prostate * Clinical stages T1b - T3a * The patient has decided to undergo brachytherapy (or brachytherapy plus external beam radiation) as a treatment modality for his prostate cancer * Karnofsky Performance Status \> 60 * Prostate volume by transrectal ultrasound (TRUS) \< 55 cc * International Prostate symptom score (IPSS) 20 or less * Ability to have Magnetic resonance imaging as part of post-implant assessment * Signed study-specific consent form prior to registration Exclusion Criteria: * Stage T3b or greater disease. * Prior history of pelvic radiation therapy * Significant obstructive symptoms (IPSS greater than 20) * Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up. * Implanted device or apparatus which obstruct visibility of the implanted sources on fluoroscopy * Metallic implants, claustrophobia not amenable to medication, or known contraindications to undergoing MR scanning
References
Publications (0)
Data not yet available
No reference posted for this study.