Cancer of Prostate
Conditions
Keywords
HIFU, Localized Prostate cancer, MRI, PSA nadir, Biopsy, High Intensity Focused Ultrasound, Prostate Specific Antigen (PSA)
Brief summary
Define the best acoustic parameters for the dynamic focusing HIFU transducer in the treatment of localized Prostate Cancer.
Interventions
DEVICEAblatherm 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.
Sponsors
EDAP TMS S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Biochemical marker measurement (mid term efficacy) | 6 months | 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) | Day 7 | Evaluate the rectal wall preservation by MRI in the first week post treatment. |
| 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. |
| Quality of life score | 3 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 | 3 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 | 3 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. |
| Adverse events reporting rates (safety and the morbidity) at 24 months | 24 months | Adverse Events reporting |
Countries
France
Outcome results
None listed