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Spots Global Cancer Trial Database for Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer

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Trial Identification

Brief Title: Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer

Official Title: Evaluation of the Feasibility and Tolerance of Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer

Study ID: NCT03023345

Study Description

Brief Summary: The purpose of this study is to determine if trans-rectal microwave ablation of the index tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using MRI-transrectal ultrasound image registration.

Detailed Description: In men with low-risk prostate cancer, European and American guidelines recommend either active surveillance or whole-gland treatments, with significant induced morbidity and burden on quality of life. Focal treatments of the index tumor are currently under investigation to decrease morbidity while proposing active treatment. The purpose of this study is to determine the feasibility, precision and safety of a novel ablation treatment using microwaves, delivered transrectally under real-time guidance with MRI-transrectal ultrasound image registration. The index tumor will be detected with prostate MRI and characterized with targeted biopsies using MRI-transrectal ultrasound image registration. It will then be ablated with microwaves using the same transrectal approach and guidance system (KOELIS).

Eligibility

Minimum Age: 45 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Assistance Publique - H么pitaux de Paris, Paris, , France

Contact Details

Name: Nicolas BARRY DELONGCHAMPS, MD, PhD

Affiliation: Assistance Publique - H么pitaux de Paris

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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