Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Conditions:
Prostate Cancer
Eligibility:
MALE
40-75 years
Phase:
NA
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:...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT06945172
Start Date
October 1 2025
End Date
December 31 2028
Last Update
September 29 2025
Active Locations (1)
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1
Clinique La Croix du Sud
Quint-Fonsegrives, France, 31130