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
NCT ID: NCT06945172
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
102 participants
INTERVENTIONAL
2025-10-01
2028-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Total prostatectomy
Patient will undergo total prostatectomy as a treatment for their cancer
Total prostatectomy
Total prostatectomy is a surgical procedure performed to treat prostate cancer.
Focal HIFU
Patient will undergo focal HIFU as a treatment for their cancer
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.
Interventions
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Total prostatectomy
Total prostatectomy is a surgical procedure performed to treat prostate cancer.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
75 Years
MALE
No
Sponsors
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GCS Ramsay Santé pour l'Enseignement et la Recherche
OTHER
Responsible Party
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Locations
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Clinique La Croix du Sud
Quint-Fonsegrives, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-A02716-41
Identifier Type: OTHER
Identifier Source: secondary_id
2024-A02716-41
Identifier Type: -
Identifier Source: org_study_id
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