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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total prostatectomy, Focal HIFU.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 40 years — 75 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure Total prostatectomy
Total prostatectomy is a surgical procedure performed to treat prostate cancer. - Procedure Focal 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.
Primary outcome measures
- Quality of Life in relation to prostate cancer [Time frame: Month 6, month 12 and month 24]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Clinique La Croix du Sud — Quint-Fonsegrives
Identifiers
NCT: NCT06945172 · 2024-A02716-41 · 2024-A02716-41