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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 | Clinical Trials | Clareo Health

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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

NCT06945172•GCS Ramsay Santé pour l'Enseignement et la Recherche

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

40 - 75 years

Sex

MALE

Healthy Volunteers

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

Locations (1)

Clinique La Croix du Sud

Quint-Fonsegrives, France

Key Dates

Start Date

October 1, 2025

Primary Completion Date

December 31, 2028

Completion Date

December 31, 2028

Last Updated

September 29, 2025

Enrollment

102

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

Total prostatectomy

PROCEDURE

Focal HIFU

PROCEDURE

Contacts

Guillaume PLOUSSARD, MD

CONTACT

+33 06 84 11 85 09 dr.gploussard@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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