Prostate Cancer
Conditions
Brief summary
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
Interventions
PROCEDURETotal prostatectomy
Total prostatectomy is a surgical procedure performed to treat prostate cancer.
PROCEDUREFocal HIFU
Focal HIFU treatment is an innovative technique that consists of destroying prostate tumour cells using high-intensity ultrasound focused exclusively on the affected area of the gland.
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life in relation to prostate cancer | Month 6, month 12 and month 24 | Quality of life in relation to prostate cancer will be assessed by the total score (ranging from 0 to 60) of the EPIC-CP (Expanded Prostate Cancer Index Composite for Clinical Practice) questionnaire. Higher score means a worse outcome. |
Countries
France
Contacts
CONTACTGuillaume PLOUSSARD, MD
Outcome results
None listed