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

NCT ID: NCT04602208

Last Updated: 2020-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-10-01

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Retrospectively review of medical data in patients treated by focal HIFU for primary localized prostate cancer

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital Edouard Herriot

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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69HCL20_0960

Identifier Type: -

Identifier Source: org_study_id