Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03023345
Recruitment Status : Active, not recruiting
First Posted : January 18, 2017
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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 Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : September 12, 2017
Actual Primary Completion Date : November 5, 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: Microwave thermal ablation system called TATO (Biomedical)




Primary Outcome Measures :
  1. Complete necrosis of the index tumor on prostate MRI [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Margins of necrosis around the index tumor on prostate MRI [ Time Frame: 7 days ]
  2. Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire [ Time Frame: 7 days ]
    to assess sexual tolerance

  3. Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire [ Time Frame: 1 month ]
    to assess sexual tolerance

  4. Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire [ Time Frame: 3 months ]
    to assess sexual tolerance

  5. Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire [ Time Frame: 6 months ]
    to assess sexual tolerance

  6. Urinary symptoms using IPSS [ Time Frame: 7 days ]
    to assess urinary tolerance

  7. Urinary symptoms using IPSS [ Time Frame: 1 month ]
    to assess urinary tolerance

  8. Urinary symptoms using IPSS [ Time Frame: 3 months ]
    to assess urinary tolerance

  9. Urinary symptoms using IPSS [ Time Frame: 6 months ]
    to assess urinary tolerance

  10. Number of cancer on targeted biopsies within the treated volume [ Time Frame: 6 months ]
    to assess oncological efficacy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023345


Locations
Layout table for location information
France
Assistance Publique - Hôpitaux de Paris
Paris, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Nicolas BARRY DELONGCHAMPS, MD, PhD Assistance Publique - Hôpitaux de Paris
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03023345    
Other Study ID Numbers: P160301
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
cancer
prostate
PSA
biopsies
microwave trans rectal focal treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases