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
Recruiting · NCT06945172 · Interventional (participants receive a specific treatment) · Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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
Where it is running
1 location listed.
- Clinique La Croix du Sud - Quint-Fonsegrives, France