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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.
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| Measure | Description | Time Frame |
|---|---|---|
| To 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. | From HIFU treatment up to 5 years post-HIFU |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From HIFU treatment up to 5 years post-HIFU |
| Incidence of local recurrence detected by prostate MRI after HIFU treatment |
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Inclusion Criteria:
Exclusion Criteria:
To have a prostate
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Patients Being treated for prostate cancer with the Focal One device
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Djamila BENNAT | Contact | +33 472153150 | dbennat@edap-tms.com | |
| Léa GUEDJ | Contact | lguedj@edap-tms.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital privé Aix en provence | Recruiting | Aix-en-Provence | 13080 | France |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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. |
| 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. | 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. | From HIFU treatment up to 5 years post-HIFU |
| Clinique Saint vincent | Recruiting | Besançon | 25056 | France |
|
| Hôpital Civil Colmar | Recruiting | Colmar | 68000 | France |
|
| Hôpital Edouard Heriot | Recruiting | Lyon | 69000 | France |
|
| Clinique Nantes Atlantis | Recruiting | Nantes | 44000 | France |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |