Dynamic Focusing Evaluation for Prostate Cancer Treatment

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

Official Title
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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

Conditions
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Cancer of Prostate

Intervention / Treatment
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* Device: Ablatherm Foc/Dyn or Focal One HIFU treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIFU prostate treatment<br>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<br>* 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.<br>* Other names: First line treatment or Salvage treatment post-radiotherapy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIFU, Localized Prostate cancer, MRI, PSA nadir, Biopsy, High Intensity Focused Ultrasound, Prostate Specific Antigen (PSA)