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
| NCT ID | NCT06945172 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2025-09-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06945172 clinical trial?
This trial is open to male participants only, aged 40 Years or older, up to 75 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06945172 currently recruiting?
Yes, NCT06945172 is actively recruiting participants. Contact the research team at dr.gploussard@gmail.com for enrollment information.
Where is the NCT06945172 trial being conducted?
This trial is being conducted at Quint-Fonsegrives, France.
Who is sponsoring the NCT06945172 clinical trial?
NCT06945172 is sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. The trial plans to enroll 102 participants.
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