Dynamic Focusing Evaluation for Prostate Cancer Treatment
- Conditions
- Cancer of Prostate
- Interventions
- Device: "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment
- Registration Number
- NCT03632980
- Lead Sponsor
- EDAP TMS S.A.
- Brief Summary
Define the best acoustic parameters for the dynamic focusing HIFU transducer in the treatment of localized Prostate Cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HIFU prostate treatment "Ablatherm Foc/Dyn" or "Focal One" HIFU 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
- Primary Outcome Measures
Name Time Method Necrosis measurement (immediate efficacy) Day 7 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
Name Time Method Adverse events reporting rates (safety and the morbidity) at 6 months 6 months Adverse Events reporting
Histological marker measurement (mid term efficacy) 6 months The mid term efficacy is evaluated by the rate of negative biopsy at 6 months.
Biochemical marker measurement (mid term efficacy) 6 months The mid term efficacy is evaluated by the percentage of patient with a PSA nadir ā¤ 0.3ng/mL
Rectal wall preservation (immediate safety and morbidity) Day 7 Evaluate the rectal wall preservation by MRI in the first week post treatment.
Adverse events reporting rates (safety and the morbidity) at 24 months 24 months Adverse Events reporting
Quality of life score 6 months 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 6 months 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 6 months 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.
Trial Locations
- Locations (1)
Edouard Herriot Hospital
š«š·Lyon, France