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

Prostate Cancer Clinical Trial

— Focal HIFU for  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602208
• Other study ID #: 69HCL20_0960
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: October 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Hopital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retreatment-free survival (RFS)	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.	May 1, 2020