Clinical trial Recruiting at 1 site Interventional Ages 40 to 75 Men only

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.

More Prostate Cancer trials

Quick facts

Study typeInterventional
Ages40 Years to 75 Years
SexMen only
Enrollment102 (estimated)
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche
Academic / other
Locations1 site (Quint-Fonsegrives)
StatusRecruiting
StartedSeptember 1, 2025
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedAugust 20, 2026
Trial IDNCT06945172 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

  • Clinique La Croix du Sud
    Quint-Fonsegrives, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.