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

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

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.

Study Overview

• Status: Completed
• Conditions: Low-Risk Prostate Cancer
• Intervention / Treatment: Device: Microwave trans rectal focal treatment

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris
    • Paris, Paris, France
      • Assistance Publique - Hôpitaux de Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete necrosis of the index tumor on prostate MRI	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	to assess sexual tolerance	7 days
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire	to assess sexual tolerance	1 month
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire	to assess sexual tolerance	3 months
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire	to assess sexual tolerance	6 months
Urinary symptoms using IPSS	to assess urinary tolerance	7 days
Urinary symptoms using IPSS	to assess urinary tolerance	1 month
Urinary symptoms using IPSS	to assess urinary tolerance	3 months
Urinary symptoms using IPSS	to assess urinary tolerance	6 months
Number of cancer on targeted biopsies within the treated volume	to assess oncological efficacy	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Unité de Recherche Clinique Necker Cochin, Fr
• Investigators: Principal Investigator: Nicolas BARRY DELONGCHAMPS, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Barry Delongchamps N, Schull A, Anract J, Abecassis JP, Zerbib M, Sibony M, Jilet L, Abdoul H, Goffin V, Peyromaure M. Feasibility and safety of targeted focal microwave ablation of the index tumor in patients with low to intermediate risk prostate cancer: Results of the FOSTINE trial. PLoS One. 2021 Jul 14;16(7):e0252040. doi: 10.1371/journal.pone.0252040. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2017
• Primary Completion (Actual): November 5, 2018
• Study Completion (Actual): April 23, 2019

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimated): January 18, 2017

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: cancer; PSA; prostate; biopsies; microwave trans rectal focal treatment
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Neoplasms
• Other Study ID Numbers: P160301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No