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Spots Global Cancer Trial Database for Efficacy Evaluation of Focused HIFU (High Intensity Focused Ultrasound) Therapy in Patients With Localized Intermediate Risk Prostate Cancer

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Trial Identification

Brief Title: Efficacy Evaluation of Focused HIFU (High Intensity Focused Ultrasound) Therapy in Patients With Localized Intermediate Risk Prostate Cancer

Official Title: Phase 2, Multicenter, Prospective Cohort Study, Estimating the Efficacy of Focused HIFU Therapy in Patients With Localized Intermediate Risk Prostate Cancer

Study ID: NCT03568188

Conditions

Prostate Cancer

Study Description

Brief Summary: The aim of the focal treatment HIFU is to destroy the cancer without causing side effects in contrast to radical treatments. Radical treatments (surgery or radiation therapy) are the standard therapies for patient with intermediate risk localized prostate cancer and good life expectancy (prostatectomy if life expectancy10 years) By destroying only the part of the gland that harbors cancer, it may indeed be possible to provide efficient cure of the disease while minimizing treatment-induced morbidity (incontinence and loss of potency). Around 20% of patients presented with a unilateral tumor: this patients are currently treated radically. No study published papers reported outcomes of a large population (\>100) with intermediate risk cancers treated with Focal-HIFU (conducted with the Focal One® device). Focal therapy must be only offer within clinical trial setting (EAU (European Association of Urology) Guidelines ). The aim of this cohort will be to determine the success rate of Focal-HIFU in this intermediate risk population. The result the study will be used for calculation the arms of a future random study

Detailed Description:

Eligibility

Minimum Age: 50 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Polyclinique du parc Rambot, Aix-en-Provence, , France

Clinique Saint-Vincent, Besançon, , France

Service d'Urologie, Clinique Tivoli Ducos, Bordeaux, , France

Groupe Hospitalier Pellegrin - CHU, Bordeaux, , France

Hôpital L. Pasteur, Hôpitaux Civils de Colmar, Colmar, , France

Service d'Urologie CHRU de Lille, Hôpital HURIEZ, Lille, , France

Service d'Urologie Générale de Santé - Hôpital Privé La Louvière, Lille, , France

Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot,, Lyon, , France

Service d'urologie Assistance Publique - Hôpitaux de Marseille - Hôpital Marseille Nord, Marseille, , France

Département d'Urologie, Institut Montsouris, Paris, , France

Centre Hospitalier Lyon Sud - Hospices Civils de Lyon, Pierre-Bénite, , France

Clinique Urologique Nantes Atlantis, Saint-Herblain, , France

Service d'Urologie, Hôpital Foch, Suresnes, , France

CHU de Toulouse - Hôpital de Rangueil, Toulouse, , France

Clinique Générale Beaulieu - Swiss International Prostate Center, Geneva, , Sweden

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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