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NCT Number: NCT06945172

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

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

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Key information

Age range

40 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total prostatectomy

Procedure

Total prostatectomy is a surgical procedure performed to treat prostate cancer.

Focal HIFU

Procedure

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 outcomes

  1. Quality of Life in relation to prostate cancer

    Time frame: Month 6, month 12 and month 24

    Quality of life in relation to prostate cancer will be assessed by the total score (ranging from 0 to 60) of the EPIC-CP (Expanded Prostate Cancer Index Composite for Clinical Practice) questionnaire. Higher score means a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume PLOUSSARD, MD

CONTACT

[email protected]

+33 06 84 11 85 09

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: QUALIFY

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 25, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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