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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-75
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total prostatectomy

    Procedure/Surgery

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

  • Focal HIFU

    Procedure/Surgery

    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.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Total prostatectomyActive comparator 1 intervention
Group B: Focal HIFUExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Month 6, month 12 and month 24

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.