NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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
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

NCT06945172

RecruitingNA

Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Conditions: Prostate Cancer

Interventions: Total prostatectomy, Focal HIFU

Countries: France

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

Eligibility overview

Sex: MALE

Age: 40 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (1)
  • Quint-Fonsegrives, France