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

Low-Risk Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023345
• Other study ID #: P160301
• Status: Completed
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: April 23, 2019

Study information

• Verified date: July 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 23, 2019
• Est. primary completion date: November 5, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Low-Risk Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Microwave trans rectal focal treatment
Microwave trans-rectal ablation of the prostatic index tumor using MRI-transrectal ultrasound image registration

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete necrosis of the index tumor on prostate MRI		7 days
Secondary	Margins of necrosis around the index tumor on prostate MRI		7 days
Secondary	Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire	to assess sexual tolerance	7 days
Secondary	Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire	to assess sexual tolerance	1 month
Secondary	Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire	to assess sexual tolerance	3 months
Secondary	Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire	to assess sexual tolerance	6 months
Secondary	Urinary symptoms using IPSS	to assess urinary tolerance	7 days
Secondary	Urinary symptoms using IPSS	to assess urinary tolerance	1 month
Secondary	Urinary symptoms using IPSS	to assess urinary tolerance	3 months
Secondary	Urinary symptoms using IPSS	to assess urinary tolerance	6 months
Secondary	Number of cancer on targeted biopsies within the treated volume	to assess oncological efficacy	6 months