146
Participants
Start Date
March 1, 2020
Primary Completion Date
May 1, 2020
Study Completion Date
October 1, 2020
Retrospectively 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.
Hopital Edouard Herriot, Lyon
Hospices Civils de Lyon
OTHER