Quality of life after total prostatectomy vs focal HIFU for favorable intermediate-risk localized prostate cancer
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
Run by GCS Ramsay Santé pour l'Enseignement et la Recherche · NCT06945172 · Data updated 2026-11-12
This study tests whether quality of life differs for men 40–75 with favorable intermediate-risk localized prostate cancer who have either total prostatectomy or focal HIFU.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 75 Years |
| Sex | Men only |
| Enrollment | 102 (estimated) |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Quint-Fonsegrives) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT06945172 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men aged 40–75 with localized, favorable intermediate-risk prostate cancer planned for either total prostatectomy or focal HIFU and who can tolerate anesthesia, have good baseline continence and erectile function, and are French-speaking.
✕Probably not a fit
Patients with advanced disease, contraindications to MRI, significant comorbidities, or those not undergoing the planned surgical approach may not experience a quality-of-life benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Men with localized, favorable intermediate-risk prostate cancer are assigned to one of two treatments—total prostatectomy or focal HIFU—to compare their cancer-related quality of life. Participants complete the EPIC-CP questionnaire at 6, 12, and 24 months after treatment to measure outcomes. The study aims to identify differences in urinary, bowel, sexual, and hormonal functions between the two approaches. It is conducted at Clinique La Croix du Sud in Quint-Fonsegrives under the lead sponsor GCS Ramsay Santé pour l'Enseignement et la Recherche.
Why it matters
Potential benefit: If successful, the trial could help patients and clinicians choose a treatment option that better preserves quality of life.
How similar studies have gone: Previous studies have explored quality of life after prostate cancer treatments, but direct comparisons between total prostatectomy and focal HIFU in this specific risk category remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Clinique La Croix du Sud
Quint-Fonsegrives, France Recruiting
Study contacts
- Study coordinator: Guillaume PLOUSSARD, MD
- Email: dr.gploussard@gmail.com
- Phone: +33 06 84 11 85 09
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.