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
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Full eligibility criteria for NCT03023345
Ages eligible for Study
45 Years to 76 Years
Genders eligible for Study
Accepts Healthy Volunteers
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+4, including targeted biopsies corresponding to less
than 50% grade 4 for the tumor
Prostate Specific Antigen <15 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.
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
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
History of allergy or non-tolerance to gadolinium salts used in MRI
Patient with a contraindication to performing an MRI
Person placed under safeguard of justice
All locations for NCT03023345
Assistance Publique - Hôpitaux de Paris
View full eligibility
Tris trial is registered with FDA with number: NCT03023345. The sponsor of the trial is Assistance Publique Hôpitaux de Paris and it is looking for 11 volunteers for the current phase.
Official trial title: Evaluation of the Feasibility and Tolerance of Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer
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