Clinical trial · Interventional
Dynamic Focusing Evaluation for Prostate Cancer Treatment
Evaluation of a Dynamic Focusing Ultrasonic Transducer for High Intensity Focused Ultrasound (HIFU) Treatment of Localized Prostate Adenocarcinoma - Dose Escalation Trial to Define the Best Acoustic Parameters
NCT03632980CI-TRIAL-00034400FOC/DYNunknownN/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)
Define the best acoustic parameters for the dynamic focusing HIFU transducer in the treatment of localized 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 |
|---|---|---|---|
| Cancer of Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HIFU prostate treatment
- description
- The HIFU intervention will concern Primary care patients or Secondary care patients (salvage). Intervention with "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment devices HIFU intervention will be administered with "Ablatherm Foc/Dyn or Focal One - First line" to Patients suffering from localized prostate cancer that has not been previously treated or Salvage HIFU intervention will be administered with "Ablatherm Foc/Dyn or Focal One - Post radiotherapy" to subjects harboring prostate cancer recurrency after radiotherapy
- interventionNames
- Device: "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment
Primary outcomes (1)
- measure
- Necrosis measurement (immediate efficacy)
- timeFrame
- Day 7
- description
- The coagulation necrosis induced by the HIFU dynamic focusing treatment of the prostate is evaluated by MRI in the first week post treatment.
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria for primary care patients: * Age \> 70 years * T1 or T2 * PSA \< 15 ng/mL * 12 randomized biopsies * Gleason score ≤ 3+4 * Normal anal and rectal anatomy * American Society of Anesthesiologists risk (ASA) 1 or 2 Exclusion Criteria for primary care patients: * T3 patients * American Society of Anesthesiologists risk (ASA) 3 * Metastatic disease (Bone scan…) * Previous prostate cancer therapy * Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness * Prostate volume over 50cc * Previous bladder cancer * contraindication to MRI * previous rectal or urinary fistulae Inclusion Criteria for salvage patients: * Age \> 50 years * T1 or T2 * Biochemical recurrence after radiotherapy (Phoenix definition: nadir+2ng/ml) * 12 randomized biopsies * Normal anal and rectal anatomy * ASA 1 or 2 Exclusion Criteria for salvage patients: * T3 patients * ASA 3 * Metastatic disease (Bone scan…) * Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness * Prostate volume over 50cc * Previous bladder cancer * contraindication to MRI * previous rectal or urinary fistulae
References
Publications (0)
Data not yet available
No reference posted for this study.