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

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

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

Study Overview

• Status: Unknown
• Conditions: Cancer of Prostate
• Intervention / Treatment: Device: "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Edouard Herriot Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: HIFU prostate treatment; 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

Device: "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment; 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.; Other Names: Ablatherm Foc/Dyn or Ablatherm Foc/Dyn post-radiotherapy; Focal One or Focal One post-radiotherapy; First line treatment or Salvage treatment post-radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological marker measurement (mid term efficacy)	The mid term efficacy is evaluated by the rate of negative biopsy at 6 months.	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	6 months
Rectal wall preservation (immediate safety and morbidity)	Evaluate the rectal wall preservation by MRI in the first week post treatment.	Day 7
Adverse events reporting rates (safety and the morbidity) at 6 months	Adverse Events reporting	6 months
Adverse events reporting rates (safety and the morbidity) at 24 months	Adverse Events reporting	24 months
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.	3 months
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.	6 months
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.	3 months
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.	6 months
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.	3 months
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.	6 months

Collaborators and Investigators

• Sponsor: EDAP TMS S.A.
• Investigators: Principal Investigator: Albert GELET, MD, Edouard Herriot Hospital, Lyon, France

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: January 31, 2012
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (ACTUAL): August 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: MRI; Biopsy; High Intensity Focused Ultrasound; HIFU; Localized Prostate cancer; Prostate Specific Antigen (PSA); PSA nadir
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HIFU/F/10.08; 2011-A00313-38 (OTHER: AFSSAPS)