Comparing two prostate cancer treatments and their effect on quality of life
Compares quality of life after surgery or focal HIFU in men with early prostate cancer.
Key facts
- Who runs it
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Where
- Quint-Fonsegrives, FranceSee the site
- Trial code
- Registry 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
- Status
- Recruiting
- People taking part
- 102 people, planned
- Started
- 1 Sept 2025
- Expected to end
- 31 Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Total prostatectomy
- Focal HIFU
- Record updated
- 20 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men aged 40 to 75 with localised prostate cancer at favourable intermediate risk. They must be treated with total prostatectomy or focal HIFU.
- Age
- 40 to 75 years
- Sex
- Men only
- Disease stage
- Localised prostate cancer at favourable intermediate risk. Stage T3a or b on MRI cannot join.
- Earlier treatment
- A treatment plan (prostatectomy or focal HIFU) must have been set at a team meeting (PCR). Not stated whether earlier cancer treatment is allowed.
Main reasons for not taking part
- Cannot have an MRI
- Stage T3a or b on MRI
- Long-term blood thinners that cannot be stopped
- Already in another study
- Adult under guardianship, curatorship or other legal protection, or deprived of liberty by court or administrative decision
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
Where in France
- Clinique La Croix Du SudQuint-Fonsegrives, FranceContact: Guillaume PLOUSSARD, MDTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
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
The 2 groups in the trial
- Total prostatectomyExisting treatment, for comparison
Patient will undergo total prostatectomy as a treatment for their cancer
- Focal HIFUTreatment being tested
Patient will undergo focal HIFU as a treatment for their cancer
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Comparing two prostate cancer treatments and their effect on quality of lifeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06945172, who can take part
- Record updated
- 20 August 2026