Clinical trial · Interventional
Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY
EVALUATION OF HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) IN CURATIVE TREATMENT OF LOCALIZED PROSTATE CANCER AT LOW OR INTERMEDIATE RISK AND IN TREATMENT OF RECURRENCE AFTER RADIOTHERAPY (FORFAIT INNOVATION ART L165-1-1 Social Security Code)
NCT04307056CI-TRIAL-00063182HIFIcompletedN/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)
to compare the efficacy of HIFU treatment with standard treatment in two situations: 1. as first-line cancer treatment, HIFU is compared to radical prostatectomy. 2. for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Ultrasound Therapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Intensity Focused Ultrasound (HIFU) Treatment | Procedure | — | UNRESOLVED |
| Radical Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HIFU
- description
- Patients Treated with high intensity focused ultrasound (HIFU)
- interventionNames
- Procedure: High Intensity Focused Ultrasound (HIFU) Treatment
- type
- ACTIVE_COMPARATOR
- label
- Prostatectomy
- description
- Patients Treated by Radical Prostatectomy
- interventionNames
- Procedure: Radical Prostatectomy
Primary outcomes (1)
- measure
- Recurrence-free survival
- timeFrame
- 30 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 70 Years
Show eligibility criteria text
General inclusion criteria * Patients with localized adenocarcinoma of the prostate classified as T1-2, N0, Nx M0 * classified as low or intermediate risk * Patient with PSA \< 15 ng/ml, Gleason score ≤ 7 restricted to the form \[3 + 4\]. * Biopsy with at least 12 specimens and a maximum of four out of six invaded sextants * Patient with a pelvic MRI if there is an intermediate risk and a bone scintigraphy if PSA \> 10 ng/ml * Patient affiliated with health insurance or beneficiary of an equivalent plan Inclusion criteria for the HIFU Arm * Patients 70 years of age or older * Patients with a life expectancy related to age and associated illness estimated to be greater than 5 years Inclusion Criteria for Total Prostatectomy Arm • Patients with a life expectancy greater than 10 years and a state of health allowing general anaesthesia. NON-INCLUSION CRITERIA * Patient participating in other biomedical research within 3 months prior to their inclusion in this protocol * Included patient simultaneously participating in another research study
References
Publications (2)
- DERIVEDPloussard G, Coloby P, Chevallier T, Occean BV, Kassab D, Houede N, Villers A, Rischmann P. Salvage High-intensity Focused Ultrasound for Prostate Cancer Recurrence after Radiotherapy (HIFI-2 Study). Eur Urol Oncol. 2026 Apr 28:S2588-9311(26)00112-4. doi: 10.1016/j.euo.2026.04.007. Online ahead of print. PMID 42055879
- DERIVEDPloussard G, Coloby P, Chevallier T, Occean BV, Houede N, Villers A, Rischmann P; HIFI group. Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial. Eur Urol. 2025 May;87(5):526-533. doi: 10.1016/j.eururo.2024.11.006. Epub 2024 Dec 4. PMID 39632125