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Dynamic Focusing Evaluation for Prostate Cancer Treatment (FOC/DYN)

Primary Purpose

Cancer of Prostate

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
"Ablatherm Foc/Dyn" or "Focal One" HIFU treatment
Sponsored by
EDAP TMS S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Prostate focused on measuring HIFU, Localized Prostate cancer, MRI, PSA nadir, Biopsy, High Intensity Focused Ultrasound, Prostate Specific Antigen (PSA)

Eligibility Criteria

70 Years - undefined (Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria for primary care patients:

  • Age > 70 years
  • T1 or T2
  • PSA < 15 ng/mL
  • 12 randomized biopsies
  • Gleason score ≤ 3+4
  • Normal anal and rectal anatomy
  • American Society of Anesthesiologists risk (ASA) 1 or 2

Exclusion Criteria for primary care patients:

  • T3 patients
  • American Society of Anesthesiologists risk (ASA) 3
  • Metastatic disease (Bone scan…)
  • Previous prostate cancer therapy
  • Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness
  • Prostate volume over 50cc
  • Previous bladder cancer
  • contraindication to MRI
  • previous rectal or urinary fistulae

Inclusion Criteria for salvage patients:

  • Age > 50 years
  • T1 or T2
  • Biochemical recurrence after radiotherapy (Phoenix definition: nadir+2ng/ml)
  • 12 randomized biopsies
  • Normal anal and rectal anatomy
  • ASA 1 or 2

Exclusion Criteria for salvage patients:

  • T3 patients
  • ASA 3
  • Metastatic disease (Bone scan…)
  • Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness
  • Prostate volume over 50cc
  • Previous bladder cancer
  • contraindication to MRI
  • previous rectal or urinary fistulae

Sites / Locations

  • Edouard Herriot Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIFU prostate treatment

Arm Description

The HIFU intervention will concern Primary care patients or Secondary care patients (salvage). Intervention with "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment devices HIFU intervention will be administered with "Ablatherm Foc/Dyn or Focal One - First line" to Patients suffering from localized prostate cancer that has not been previously treated or Salvage HIFU intervention will be administered with "Ablatherm Foc/Dyn or Focal One - Post radiotherapy" to subjects harboring prostate cancer recurrency after radiotherapy

Outcomes

Primary Outcome Measures

Necrosis measurement (immediate efficacy)
The coagulation necrosis induced by the HIFU dynamic focusing treatment of the prostate is evaluated by MRI in the first week post treatment.

Secondary Outcome Measures

Histological marker measurement (mid term efficacy)
The mid term efficacy is evaluated by the rate of negative biopsy at 6 months.
Biochemical marker measurement (mid term efficacy)
The mid term efficacy is evaluated by the percentage of patient with a PSA nadir ≤ 0.3ng/mL
Rectal wall preservation (immediate safety and morbidity)
Evaluate the rectal wall preservation by MRI in the first week post treatment.
Adverse events reporting rates (safety and the morbidity) at 6 months
Adverse Events reporting
Adverse events reporting rates (safety and the morbidity) at 24 months
Adverse Events reporting
Quality of life score
Quality of life will be assessed using the QLQC30 (Quality of Life questionnaire) questionnaire. It is a specific questionnaire to determine the quality of life a patient with cancer. It is composed of 30 questions with 4 potential answers going from: not at all, a little, enough or a lot, within 28 questions and with a visual scale going from 1 to 7 (7 being excellent and 1 being very bad) for the last 2 questions. The raw score is established by adding the score of each question and a linear transformation range it from 0 to 100. The higher the score, the worse the quality of life.
Quality of life score
Quality of life will be assessed using the QLQC30 (Quality of Life questionnaire) questionnaire. It is a specific questionnaire to determine the quality of life a patient with cancer. It is composed of 30 questions with 4 potential answers going from: not at all, a little, enough or a lot, within 28 questions and with a visual scale going from 1 to 7 (7 being excellent and 1 being very bad) for the last 2 questions. The raw score is established by adding the score of each question and a linear transformation range it from 0 to 100. The higher the score, the worse the quality of life.
IPSS score
Urinary function will be assessed using the IPSS (International Prostate Score Symptom) questionnaire. The IPSS questionnaire is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35. The score is then categorized as follow: Mild (symptoms score less than or equal to 7), Moderate (symptom score range 8-19), Severe (symptom score range 20-35). The higher the score, the worse the symptoms.
IPSS score
Urinary function will be assessed using the IPSS (International Prostate Score Symptom) questionnaire. The IPSS questionnaire is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35. The score is then categorized as follow: Mild (symptoms score less than or equal to 7), Moderate (symptom score range 8-19), Severe (symptom score range 20-35). The higher the score, the worse the symptoms.
IIEF-5 score
Sexual function will be assessed using the IIEF-5 (The International Index of Erectile Function) questionnaire. The IIEF-5 Questionnaire is composed of 5 items with 5 possible answers rating from 1 to 5 (very low, low, moderate, high, very high). The score is the sum of the ordinal responses to the 56 items. It is then categorized as follow: 22-25: No erectile dysfunction, 17-21: Mild erectile dysfunction, 12-16: Mild to moderate erectile dysfunction, 8-11: Moderate erectile dysfunction, 5-7: Severe erectile dysfunction. The higher the score, the better the sexual function.
IIEF-5 score
Sexual function will be assessed using the IIEF-5 (The International Index of Erectile Function) questionnaire. The IIEF-5 Questionnaire is composed of 5 items with 5 possible answers rating from 1 to 5 (very low, low, moderate, high, very high). The score is the sum of the ordinal responses to the 56 items. It is then categorized as follow: 22-25: No erectile dysfunction, 17-21: Mild erectile dysfunction, 12-16: Mild to moderate erectile dysfunction, 8-11: Moderate erectile dysfunction, 5-7: Severe erectile dysfunction. The higher the score, the better the sexual function.

Full Information

First Posted
January 31, 2012
Last Updated
August 13, 2018
Sponsor
EDAP TMS S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03632980
Brief Title
Dynamic Focusing Evaluation for Prostate Cancer Treatment
Acronym
FOC/DYN
Official Title
Evaluation of a Dynamic Focusing Ultrasonic Transducer for High Intensity Focused Ultrasound (HIFU) Treatment of Localized Prostate Adenocarcinoma - Dose Escalation Trial to Define the Best Acoustic Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EDAP TMS S.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Define the best acoustic parameters for the dynamic focusing HIFU transducer in the treatment of localized Prostate Cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Prostate
Keywords
HIFU, Localized Prostate cancer, MRI, PSA nadir, Biopsy, High Intensity Focused Ultrasound, Prostate Specific Antigen (PSA)

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
HIFU prostate treatment
Arm Type
Experimental
Arm Description
The HIFU intervention will concern Primary care patients or Secondary care patients (salvage). Intervention with "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment devices HIFU intervention will be administered with "Ablatherm Foc/Dyn or Focal One - First line" to Patients suffering from localized prostate cancer that has not been previously treated or Salvage HIFU intervention will be administered with "Ablatherm Foc/Dyn or Focal One - Post radiotherapy" to subjects harboring prostate cancer recurrency after radiotherapy
Intervention Type
Device
Intervention Name(s)
"Ablatherm Foc/Dyn" or "Focal One" HIFU treatment
Other Intervention Name(s)
Ablatherm Foc/Dyn or Ablatherm Foc/Dyn post-radiotherapy, Focal One or Focal One post-radiotherapy, First line treatment or Salvage treatment post-radiotherapy
Intervention Description
Non invasive treatment of localized prostate cancer by High Intensity Focused Ultrasound therapy, endorectal application. or Non invasive treatment of localized prostate cancer recurrency by High Intensity Focused Ultrasound therapy after radiotherapy failure, endorectal application.
Primary Outcome Measure Information:
Title
Necrosis measurement (immediate efficacy)
Description
The coagulation necrosis induced by the HIFU dynamic focusing treatment of the prostate is evaluated by MRI in the first week post treatment.
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Histological marker measurement (mid term efficacy)
Description
The mid term efficacy is evaluated by the rate of negative biopsy at 6 months.
Time Frame
6 months
Title
Biochemical marker measurement (mid term efficacy)
Description
The mid term efficacy is evaluated by the percentage of patient with a PSA nadir ≤ 0.3ng/mL
Time Frame
6 months
Title
Rectal wall preservation (immediate safety and morbidity)
Description
Evaluate the rectal wall preservation by MRI in the first week post treatment.
Time Frame
Day 7
Title
Adverse events reporting rates (safety and the morbidity) at 6 months
Description
Adverse Events reporting
Time Frame
6 months
Title
Adverse events reporting rates (safety and the morbidity) at 24 months
Description
Adverse Events reporting
Time Frame
24 months
Title
Quality of life score
Description
Quality of life will be assessed using the QLQC30 (Quality of Life questionnaire) questionnaire. It is a specific questionnaire to determine the quality of life a patient with cancer. It is composed of 30 questions with 4 potential answers going from: not at all, a little, enough or a lot, within 28 questions and with a visual scale going from 1 to 7 (7 being excellent and 1 being very bad) for the last 2 questions. The raw score is established by adding the score of each question and a linear transformation range it from 0 to 100. The higher the score, the worse the quality of life.
Time Frame
3 months
Title
Quality of life score
Description
Quality of life will be assessed using the QLQC30 (Quality of Life questionnaire) questionnaire. It is a specific questionnaire to determine the quality of life a patient with cancer. It is composed of 30 questions with 4 potential answers going from: not at all, a little, enough or a lot, within 28 questions and with a visual scale going from 1 to 7 (7 being excellent and 1 being very bad) for the last 2 questions. The raw score is established by adding the score of each question and a linear transformation range it from 0 to 100. The higher the score, the worse the quality of life.
Time Frame
6 months
Title
IPSS score
Description
Urinary function will be assessed using the IPSS (International Prostate Score Symptom) questionnaire. The IPSS questionnaire is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35. The score is then categorized as follow: Mild (symptoms score less than or equal to 7), Moderate (symptom score range 8-19), Severe (symptom score range 20-35). The higher the score, the worse the symptoms.
Time Frame
3 months
Title
IPSS score
Description
Urinary function will be assessed using the IPSS (International Prostate Score Symptom) questionnaire. The IPSS questionnaire is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35. The score is then categorized as follow: Mild (symptoms score less than or equal to 7), Moderate (symptom score range 8-19), Severe (symptom score range 20-35). The higher the score, the worse the symptoms.
Time Frame
6 months
Title
IIEF-5 score
Description
Sexual function will be assessed using the IIEF-5 (The International Index of Erectile Function) questionnaire. The IIEF-5 Questionnaire is composed of 5 items with 5 possible answers rating from 1 to 5 (very low, low, moderate, high, very high). The score is the sum of the ordinal responses to the 56 items. It is then categorized as follow: 22-25: No erectile dysfunction, 17-21: Mild erectile dysfunction, 12-16: Mild to moderate erectile dysfunction, 8-11: Moderate erectile dysfunction, 5-7: Severe erectile dysfunction. The higher the score, the better the sexual function.
Time Frame
3 months
Title
IIEF-5 score
Description
Sexual function will be assessed using the IIEF-5 (The International Index of Erectile Function) questionnaire. The IIEF-5 Questionnaire is composed of 5 items with 5 possible answers rating from 1 to 5 (very low, low, moderate, high, very high). The score is the sum of the ordinal responses to the 56 items. It is then categorized as follow: 22-25: No erectile dysfunction, 17-21: Mild erectile dysfunction, 12-16: Mild to moderate erectile dysfunction, 8-11: Moderate erectile dysfunction, 5-7: Severe erectile dysfunction. The higher the score, the better the sexual function.
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for primary care patients: Age > 70 years T1 or T2 PSA < 15 ng/mL 12 randomized biopsies Gleason score ≤ 3+4 Normal anal and rectal anatomy American Society of Anesthesiologists risk (ASA) 1 or 2 Exclusion Criteria for primary care patients: T3 patients American Society of Anesthesiologists risk (ASA) 3 Metastatic disease (Bone scan…) Previous prostate cancer therapy Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness Prostate volume over 50cc Previous bladder cancer contraindication to MRI previous rectal or urinary fistulae Inclusion Criteria for salvage patients: Age > 50 years T1 or T2 Biochemical recurrence after radiotherapy (Phoenix definition: nadir+2ng/ml) 12 randomized biopsies Normal anal and rectal anatomy ASA 1 or 2 Exclusion Criteria for salvage patients: T3 patients ASA 3 Metastatic disease (Bone scan…) Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness Prostate volume over 50cc Previous bladder cancer contraindication to MRI previous rectal or urinary fistulae
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert GELET, MD
Organizational Affiliation
Edouard Herriot Hospital, Lyon, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edouard Herriot Hospital
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

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Dynamic Focusing Evaluation for Prostate Cancer Treatment

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