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Evaluation of Focal Treatments of Localized Prostate Cancers With High Intensity Focused Ultrasound Using the Focal One® Device | Clinical Trials | Clareo Health

COMPLETEDNA

Evaluation of Focal Treatments of Localized Prostate Cancers With High Intensity Focused Ultrasound Using the Focal One® Device

NCT02662673•Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

Focal treatment of localized prostate cancer aims to destroy the cancerous foci without damaging surrounding tissues to avoid the side effects of radical treatments. This is why focal treatment is positioned as an alternative to radical surgery as well as an alternative to active surveillance. This study is a feasibility study. It aims at treating the index tumor (the most aggressive one) which determines the vital prognosis of patient, while preserving the maximum surrounding prostatic tissue to preserve quality of life. The expected result is the total destruction of aggressive tumor areas by focal or multifocal treatment strategy using the Focal One® device (EDAP-TMS, Vaulx-en-Velin, France). The tumor destruction is validated by the negative biopsy rate between 6 and 12 months post-treatment.

Eligibility

Age

50 - 80 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Age between 50 and 80 years (inclusive) with a life expectancy of more than 5 years.
•PSA ≤ 10 ng / mL.
•Initial diagnosis of localized prostate cancer (stage T1 or T2).
•Diagnosis confirmed by a multiparametric MRI and subsequent systematic and targeted prostate biopsies (at least 12 sextant biopsies and two biopsies per MRI target).
•Identification of a primary cancer site (index tumor) possibly associated with a second independent tumor (accessory tumor), provided that these tumors are separated by a sextant or the median line.
•Maximum two cancer foci, each one fulfilling the following conditions
•Gleason score of 6 AND biopsy invasion length ≥5 mm,
•OR Gleason score of 6 AND corresponding focal lesion on MRI with a PIRADS (Prostate Imaging Reporting and Data System) score ≥4/5 and a diameter ≥5 mm,
•OR Gleason score of 7 (3+4) whatever the biopsy invasion length or the MRI results may be.
•Patient with normal anal and rectal anatomy.
+4 more criteria

Exclusion Criteria

•Patient with ASA (American Society of Anesthesiologists) score 3.
•Patient clinical stage T3.
•Metastatic or distant (CT and/or MRI) lymph node.
•Patient with more than two cancer foci.
•Patients already treated for his prostate cancer (hormone therapy, radiotherapy, surgery).
•Patient having a distance between the rectal mucosa and the prostatic capsule over 8 mm.
•History of inflammatory bowel disease, rectal or urinary tract fistula.
•History of pelvic radiotherapy.
•History of bladder cancer.
•History of sclerosis of the bladder neck or urethral stricture.
+15 more criteria

Locations (1)

Hospices Civils de Lyon - Hôpital Edouard Herriot

Lyon, France

Key Dates

Start Date

January 13, 2014

Primary Completion Date

January 1, 2016

Completion Date

February 23, 2017

Last Updated

February 28, 2018

Enrollment

ACTUAL participants

Conditions

Localized Prostate Cancer

Interventions

Focal High Intensity Focused Ultrasound (HIFU) treatment

DEVICE

Radical Hypofractionated Radiotherapy for Localized Prostate Cancer

NCT06325774

Localized Prostate Cancer

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NOT_YET_RECRUITINGPHASE2

A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.

NCT07450599

High-Risk Localized Prostate Cancer

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COMPLETEDPHASE3

Treatment Decision Making in Early-Stage Prostate Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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