Clinical trial · Observational
FOCAL HIGH-INTENSITY FOCUSED ULTRASOUND FOR PRIMARY LOCALIZED PROSTATE CANCER: MIDTERM ONCOLOGICAL OUTCOMES
NCT04602208CI-TRIAL-00047908Focal HIFU forcompletedClinicalTrials.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)
Single-center evaluation of all patients treated for primary localized prostate cancer with focal HIFU from November 2009 to December 2016. To evaluate midterm oncological outcomes of focal HIFU therapy in low an intermediate risk 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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Retrospectively review of medical data in patients treated by focal HIFU for primary localized prostate cancer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Focal HIFU for primary localized prostate cancer
- description
- Between November 2009 and December 2016, at Edouard Herriot Hospital (Lyon, France), 146 consecutive patients were treated with focal HIFU for primary localized prostate cancer. Focal therapy was offered for low or intermediate risk disease (inclusion criteria: one tumor localized by systematic and targeted biopsies based on MRI findings, Gleason ≤7). Treatment failure was defined as local or systemic salvage treatment, a positive biopsy Gleason score of 7 or greater in-field or out-of-field in nontreated patients, prostate cancer metastasis or prostate cancer specific death.
- interventionNames
- Procedure: Retrospectively review of medical data in patients treated by focal HIFU for primary localized prostate cancer
Primary outcomes (1)
- measure
- Retreatment-free survival (RFS)
- timeFrame
- May 1, 2020
- description
- The study primary outcome was retreatment-free survival (RFS) defined as any additional further treatment: local (FT/PGA for in-field or out-of-field recurrences or radical prostatectomy or external beam radiotherapy or whole gland HIFU) or systemic salvage treatment, a positive biopsy revealing PCa with an ISUP grade≥ 2 in nontreated patients, PCa metastasis or PCa specific death.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * • The patients with low or intermediate risk PCa (PSA \<20 ng/ml, Gleason score 7 or less and clinical stage T2b or less) who received PGA/FT using HIFU were included. Exclusion Criteria: * Patients who were previously treated with radiotherapy, androgen deprivation therapy (ADT) or other treatment for their prostate cancer were excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.