The aim of the registry is to gather real-life data to evaluate the clinical performance and safety of medical devices in patients who have been treated with HIFU thank to the Focal One device for their prostate cancer.
It is a prospective and retrospective register.
Study Type
OBSERVATIONAL
Enrollment
3,000
Hôpital privé Aix en provence
Aix-en-Provence, France
RECRUITINGClinique Saint vincent
Besançon, France
RECRUITINGHôpital Civil Colmar
Colmar, France
RECRUITINGTo monitor the safety of HIFU treatment with the Focal One in patients treated for prostate cancer.
Safety will be assessed by collecting adverse events related to HIFU treatment.
Time frame: From HIFU treatment up to 5 years post-HIFU
PSA values after HIFU treatment
Oncological outcomes will be assessed using PSA measurements obtained as part of routine care. The outcome will be reported as PSA values measured during follow-up after HIFU treatment.
Time frame: From HIFU treatment up to 5 years post-HIFU
Incidence of local recurrence detected by prostate MRI after HIFU treatment
Local recurrence will be assessed using prostate MRI performed as part of routine care. The outcome will be reported as the number and proportion of patients with imaging findings suspicious for local recurrence.
Time frame: From HIFU treatment up to 5 years post-HIFU
Prostate biopsy results after HIFU treatment
Oncological outcomes will be assessed using prostate biopsy results obtained as part of routine care. The outcome will be reported as the number and proportion of patients with positive biopsy findings during follow-up after HIFU treatment.
Time frame: From HIFU treatment up to 5 years post-HIFU
To estimate the retreatment rate of patients treated with HIFU
The rate and timing of retreatment (radical prostatectomy, radiotherapy, cryotherapy, HIFU, other focal treatment) after HIFU treatment will be assessed using data from the patient's clinical follow-up.
Time frame: From HIFU treatment up to 5 years post-HIFU
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hôpital Edouard Heriot
Lyon, France
RECRUITINGClinique Nantes Atlantis
Nantes, France
RECRUITING