Clinical trial · Observational
ES-HIFU, Prospective Data Collection of Patients Treated With Partial Gland HIFU Ablation for Prostate Cancer
A Multi-institutional Prospective Data Collection of Patients Treated With Partial Gland High-Intensity Focused Ultrasound (HIFU) Ablation for Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated early to integrate sites into a larger registry for a more comprehensive dataset, and not due to any safety concerns.
Summary
Brief summary (as posted)
The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device.
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FocalOne | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Evaluation of adverse events
- timeFrame
- 1 year
- description
- using the Clavien-Dindo classification
- measure
- Evaluation of quality of life
- timeFrame
- 3, 6, 9 and 12 months
- description
- IQL questionnaires
- measure
- Evaluation of urinary incontinence
- timeFrame
- 3, 6, 9 and 12 months
- description
- ICIQ questionnaire
- measure
- Erectile function assessment
- timeFrame
- 3, 6, 9 and 12 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient eligible for HIFU treatment for prostate cancer, excluding whole gland treatment. * Patient newly diagnosed with localized prostate cancer confirmed with an image guided biopsy (MRI and/or micro-ultrasounds). * Gleason ≤ 4+3. * Patient scheduled for HIFU treatment as determined by the physician. * Patient with healthcare coverage. Spanish-speaking patients with the ability to provide informed written consent Exclusion Criteria: * Patient with bilateral prostate cancer requiring whole gland treatment. * Patients clinically detected metastasis. * Patient with an extension of cancer or seminal vesicle invasion. * Patient with contraindications for HIFU treatment: please refer to the complete Focal One user manual.
References
Publications (0)
Data not yet available