NCT06945172

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
32mo left

Started Oct 2025

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Oct 2025Dec 2028

First Submitted

Initial submission to the registry

April 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 29, 2025

Status Verified

April 1, 2025

Enrollment Period

3.3 years

First QC Date

April 18, 2025

Last Update Submit

September 26, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Quality of Life in relation to prostate cancer

    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.

    Month 6, month 12 and month 24

Study Arms (2)

Total prostatectomy

ACTIVE COMPARATOR

Patient will undergo total prostatectomy as a treatment for their cancer

Procedure: Total prostatectomy

Focal HIFU

EXPERIMENTAL

Patient will undergo focal HIFU as a treatment for their cancer

Procedure: Focal HIFU

Interventions

Total prostatectomyPROCEDURE

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

Total prostatectomy
Focal HIFUPROCEDURE

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.

Focal HIFU

Eligibility Criteria

Age40 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThis study deals with prostate cancer so that only men are eligible to participate
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient, male, aged between ≥ 40 and ≤ 75 years
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique La Croix du Sud

Quint-Fonsegrives, 31130, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Guillaume PLOUSSARD, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2025

First Posted

April 25, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

September 29, 2025

Record last verified: 2025-04

Locations

FR(1)