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

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Retrospectively review of medical data in patients treated by focal HIFU for primary localized prostate cancer

• Registration Number: NCT04602208
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2020-05-01
• Status Verified: 2020-10
• Study Completion: 2020-10-01
• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-10-20
• Last Update Submitted: 2020-10-20
• Study First Posted: 2020-10-26
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 146

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.

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Exclusion Criteria

• Patients who were previously treated with radiotherapy, androgen deprivation therapy (ADT) or other treatment for their prostate cancer were excluded.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Focal HIFU for primary localized prostate cancer	Retrospectively review of medical data in patients treated by focal HIFU for primary localized prostate cancer	Between November 2009 and December 2016, at Edouard Herriot Hospital (Lyon, France), 146 consecutive patients were treated with focal HIFU for primary localized prostate cancer. Focal therapy was offered for low or intermediate risk disease (inclusion criteria: one tumor localized by systematic and targeted biopsies based on MRI findings, Gleason ≤7). Treatment failure was defined as local or systemic salvage treatment, a positive biopsy Gleason score of 7 or greater in-field or out-of-field in nontreated patients, prostate cancer metastasis or prostate cancer specific death.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hopital Edouard Herriot; 🇫🇷 Lyon, France