Clinical trial · Interventional
Comparison of Prostate Cancer-related Quality of Life in Sexually Active Men With Favourable Intermediate-risk Localised Prostate Cancer Treated With Total Prostatectomy or Focal HIFU
- 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 goal of this trial is to assess the impact of focal HIFU therapy on quality of life in patients with favourable intermediate-risk localised prostate cancer. The main question it aims to answer is: What is the prostate cancer-related quality of life in patients with favourable intermediate-risk localised cancer treated by total prostatectomy or focal HIFU ? Researchers will compare patients with favourable intermediate-risk localised cancer treated by total prostatectomy to patients with favourable intermediate-risk localised cancer treated by focal HIFU to see their quality of life. Participants will answer EPIC-CP questionnaire 6 months, 12 months and 24 months after treatment
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Focal HIFU | Procedure | — | UNRESOLVED |
| Total prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Total prostatectomy
- description
- Patient will undergo total prostatectomy as a treatment for their cancer
- interventionNames
- Procedure: Total prostatectomy
- type
- EXPERIMENTAL
- label
- Focal HIFU
- description
- Patient will undergo focal HIFU as a treatment for their cancer
- interventionNames
- Procedure: Focal HIFU
Primary outcomes (1)
- measure
- Quality of Life in relation to prostate cancer
- timeFrame
- Month 6, month 12 and month 24
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patient, male, aged between ≥ 40 and ≤ 75 years * Patient with a life expectancy \> 10 years at the time of inclusion. * Patient with a therapeutic strategy (prostatectomy or focal HIFU) defined during a PCR. * Patient with a diagnosis of localised prostate cancer at favourable intermediate risk * Patient able to tolerate general anaesthesia or type IV sedation * Patient with normal urinary continence status * Patient with satisfactory erectile function allowing penetration: * Patient with targeted biopsies and systematic biopsies * Patient affiliated to or benefiting from a social security scheme * French-speaking patients who do not object to the use of their data. Exclusion Criteria: * Patients with a contraindication to MRI * Stage T3a or b on MRI * Patient on long-term anticoagulants and unable to stop them. * Patient already included in another study * Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
References
Publications (0)
Data not yet available