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Evaluation of the Feasibility and Tolerance of Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer (NCT03023345)

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.
  • Device: Microwave trans rectal focal treatment
    Microwave trans-rectal ablation of the prostatic index tumor using MRI-transrectal ultrasound image registration
    • Microwave thermal ablation system called TATO (Biomedical)
Ages eligible for Study
45 Years to 76 Years
Genders eligible for Study
Male
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • Patients aged from 45 to 76 years old ;
  • Life expectancy above 10 years ;
  • Diagnosis of prostate cancer confirmed on prostate biopsies ;
  • Low risk of progression, defined with D'Amico criteria :
  • T1c or T2a stage
  • Maximum Gleason score of 3+3, including targeted biopsies
  • Prostate Specific Antigen <10 ng/mL
  • Detection of the index tumor with prostate MRI, characterized with targeted biopsies using MRI-transrectal ultrasound image registration ;
  • Patient accepting to be followed after the procedure using active surveillance protocol standards ;
  • Patient affiliated to national health care insurance ;
  • Free consent, informed and written, dated and signed by the patient and the investigator before enrollment.
Exclusion Criteria:
  • Medical past history of prostatic surgery ;
  • Medical past history of radiotherapy or pelvic trauma ;
  • Medical past history of acute or chronic prostatitis
  • severe BPH-related urinary tract symptoms defined as an IPSS >18 ;
  • Extra-capsular extension or seminal vesicle invasion on prostate MRI.
  • Tumor involvement > 3 mm on systematic biopsies outside the tumor volume detected on MRI.
  • Tumor largest axis > 20 mm on prostate MRI ;
  • Distance of less than 5 mm between the tumor and the rectum
  • Patient unable to understand the course of the study
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).

1 locations

France (1)
  • Assistance Publique - Hôpitaux de Paris
    not yet recruiting
    Paris, France
Status:
not yet recruiting
Type:
Interventional
Phase:
-
Start:
31 December, 2016
Updated:
23 January, 2017
Participants:
5
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