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Search / Trial 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

Launched by GCS RAMSAY SANTÉ POUR L'ENSEIGNEMENT ET LA RECHERCHE · Apr 18, 2025

Trial Information

Current as of August 20, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how two different treatments for localized prostate cancer affect the quality of life for men. Specifically, it compares total prostatectomy (surgery to remove the prostate) with focal HIFU (a non-invasive treatment that uses high-intensity focused ultrasound) in men who are still sexually active and have a favorable intermediate-risk form of prostate cancer. The main question the researchers want to answer is how these treatments impact daily living and well-being over time.

To participate in the study, men aged 40 to 75 who have been diagnosed with localized prostate cancer and can tolerate anesthesia might be eligible. Participants will complete a questionnaire about their quality of life at different points after their treatment—six months, one year, and two years after. It's important to note that the study is not yet recruiting participants and is focused on French-speaking men who agree to share their health data. If you or someone you know fits this description and is interested in how these treatments may impact life after cancer, this study could provide valuable insights.

Gender

MALE

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

About Gcs Ramsay Santé Pour L'enseignement Et La Recherche

GCS Ramsay Santé pour l'Enseignement et la Recherche is a leading clinical trial sponsor dedicated to advancing healthcare through innovative research and education. As a collaborative group, it unites academic institutions and healthcare professionals to facilitate high-quality clinical trials that enhance patient care and contribute to medical knowledge. With a focus on rigorous scientific standards and ethical practices, GCS Ramsay Santé plays a crucial role in the development of new therapies and treatment protocols, ensuring that cutting-edge research translates into tangible benefits for patients and the broader community.

Locations

Quint Fonsegrives, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported