Prostate Cancer
Conditions
Brief summary
Single-center evaluation of all patients treated for primary localized prostate cancer with focal HIFU from November 2009 to December 2016. To evaluate midterm oncological outcomes of focal HIFU therapy in low an intermediate risk prostate cancer.
Interventions
PROCEDURERetrospectively review of medical data in patients treated by focal HIFU for primary localized prostate cancer
This study concern the patients with localized prostate cancer treated by Focal HIFU for low or intermediate risk disease. Three surgeons experienced in HIFU performed the procedures. Patients were treated with the Ablatherm device \[EDAP TMS S.A., Vaulx-en-Velin, France\] until July 2013 and then with the Focal-One device \[EDAP TMS S.A.\]. The data of all the patients treated between November 2009 to December 2016, at Edouard Herriot Hospital (Lyon, France), were prospectively maintain within a central database and retrospectively reviewed. The study primary outcome was retreatment-free survival (RFS) defined as any additional further treatment: local (FT/PGA for in-field or out-of-field recurrences or radical prostatectomy or external beam radiotherapy or whole gland HIFU) or systemic salvage treatment, a positive biopsy revealing PCa with an ISUP grade≥ 2 in nontreated patients, PCa metastasis or PCa specific death. The adverse events and functional outcomes were also evaluated.
Sponsors
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • The patients with low or intermediate risk PCa (PSA \<20 ng/ml, Gleason score 7 or less and clinical stage T2b or less) who received PGA/FT using HIFU were included.
Exclusion criteria
* Patients who were previously treated with radiotherapy, androgen deprivation therapy (ADT) or other treatment for their prostate cancer were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retreatment-free survival (RFS) | May 1, 2020 | The study primary outcome was retreatment-free survival (RFS) defined as any additional further treatment: local (FT/PGA for in-field or out-of-field recurrences or radical prostatectomy or external beam radiotherapy or whole gland HIFU) or systemic salvage treatment, a positive biopsy revealing PCa with an ISUP grade≥ 2 in nontreated patients, PCa metastasis or PCa specific death. |
Countries
France
Outcome results
None listed