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NCT06945172 | NOT YET RECRUITING | Prostate Cancer

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
Sponsor:

GCS Ramsay Health for Teaching and Research

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

Condition or disease

Prostate Cancer

Intervention/treatment

Total prostatectomy

Focal HIFU

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 102 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : 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
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2028-12-31
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 75 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
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
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

Location Details

NCT06945172

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France,

La Croix du Sud clinic

Quint-Fonsegrives, France, 31130