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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT03023345

Collaborator

(none)

Enrollment

Location

Arm

19.3

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low-Risk Prostate Cancer	Device: Microwave trans rectal focal treatment	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 12, 2017

Actual Primary Completion Date :

Nov 5, 2018

Actual Study Completion Date :

Apr 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Microwave Microwave trans rectal focal treatment	Device: Microwave trans rectal focal treatment Microwave trans-rectal ablation of the prostatic index tumor using MRI-transrectal ultrasound image registration Other Names: Microwave thermal ablation system called TATO (Biomedical)

Arm

Intervention/Treatment

Experimental: Microwave

Microwave trans rectal focal treatment

Device: Microwave trans rectal focal treatment

Microwave trans-rectal ablation of the prostatic index tumor using MRI-transrectal ultrasound image registration

Other Names:

Microwave thermal ablation system called TATO (Biomedical)

Outcome Measures

Primary Outcome Measures

Complete necrosis of the index tumor on prostate MRI [7 days]

Secondary Outcome Measures

Margins of necrosis around the index tumor on prostate MRI [7 days]
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire [7 days]
to assess sexual tolerance
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire [1 month]
to assess sexual tolerance
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire [3 months]
to assess sexual tolerance
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire [6 months]
to assess sexual tolerance
Urinary symptoms using IPSS [7 days]
to assess urinary tolerance
Urinary symptoms using IPSS [1 month]
to assess urinary tolerance
Urinary symptoms using IPSS [3 months]
to assess urinary tolerance
Urinary symptoms using IPSS [6 months]
to assess urinary tolerance
Number of cancer on targeted biopsies within the treated volume [6 months]
to assess oncological efficacy

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 76 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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+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.

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
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