FOCAL HIGH-INTENSITY FOCUSED ULTRASOUND FOR PRIMARY LOCALIZED PROSTATE CANCER: MIDTERM ONCOLOGICAL OUTCOMES

CompletedOBSERVATIONAL
Enrollment

146

Participants

Timeline

Start Date

March 1, 2020

Primary Completion Date

May 1, 2020

Study Completion Date

October 1, 2020

Conditions
Prostate Cancer
Interventions
PROCEDURE

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.

Trial Locations (1)

Unknown

Hopital Edouard Herriot, Lyon

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT04602208 - FOCAL HIGH-INTENSITY FOCUSED ULTRASOUND FOR PRIMARY LOCALIZED PROSTATE CANCER: MIDTERM ONCOLOGICAL OUTCOMES | Biotech Hunter | Biotech Hunter