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

Primary Purpose

Low-Risk Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Microwave trans rectal focal treatment
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low-Risk Prostate Cancer focused on measuring cancer, prostate, PSA, biopsies, microwave trans rectal focal treatment

Eligibility Criteria

45 Years - 76 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Assistance Publique - Hôpitaux de Paris

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microwave

Arm Description

Microwave trans rectal focal treatment

Outcomes

Primary Outcome Measures

Complete necrosis of the index tumor on prostate MRI

Secondary Outcome Measures

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

Full Information

First Posted
January 13, 2017
Last Updated
July 31, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03023345
Brief Title
Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer
Acronym
FOSTINE
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 Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
November 5, 2018 (Actual)
Study Completion Date
April 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-Risk Prostate Cancer
Keywords
cancer, prostate, PSA, biopsies, microwave trans rectal focal treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microwave
Arm Type
Experimental
Arm Description
Microwave trans rectal focal treatment
Intervention Type
Device
Intervention Name(s)
Microwave trans rectal focal treatment
Other Intervention Name(s)
Microwave thermal ablation system called TATO (Biomedical)
Intervention Description
Microwave trans-rectal ablation of the prostatic index tumor using MRI-transrectal ultrasound image registration
Primary Outcome Measure Information:
Title
Complete necrosis of the index tumor on prostate MRI
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Margins of necrosis around the index tumor on prostate MRI
Time Frame
7 days
Title
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
Description
to assess sexual tolerance
Time Frame
7 days
Title
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
Description
to assess sexual tolerance
Time Frame
1 month
Title
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
Description
to assess sexual tolerance
Time Frame
3 months
Title
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
Description
to assess sexual tolerance
Time Frame
6 months
Title
Urinary symptoms using IPSS
Description
to assess urinary tolerance
Time Frame
7 days
Title
Urinary symptoms using IPSS
Description
to assess urinary tolerance
Time Frame
1 month
Title
Urinary symptoms using IPSS
Description
to assess urinary tolerance
Time Frame
3 months
Title
Urinary symptoms using IPSS
Description
to assess urinary tolerance
Time Frame
6 months
Title
Number of cancer on targeted biopsies within the treated volume
Description
to assess oncological efficacy
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas BARRY DELONGCHAMPS, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hôpitaux de Paris
City
Paris
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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