Prostate Cancer, Ultrasound Therapy
Conditions
Keywords
HIFU
Brief summary
to compare the efficacy of HIFU treatment with standard treatment in two situations: 1. as first-line cancer treatment, HIFU is compared to radical prostatectomy. 2. for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy.
Interventions
PROCEDURERadical Prostatectomy
The surgical approach can be open or laparoscopic. The procedure begins with lymph node dissection for the intermediate risk groups (PSA \> 10 ng/mL and/or presence of grade 4 Gleason score). Total prostatectomy includes removal of the seminal vesicles. It can preserve 1 or 2 neurovascular bundles, depending on the cancer stage and/or the choice expressed by the patient. The vesicourethral suture is either a running or interrupted suture, and there is drainage by a bladder catheter for at least 5 days.
PROCEDUREHigh Intensity Focused Ultrasound (HIFU) Treatment
The treatment with High Intensity Focused Ultrasound (HIFU) evaluated in this study will be delivered by 2 types of medical devices currently available on the market, Ablatherm® and Focal One®. They are both computer-controlled and provided with an endo-rectal probe with integrated ultrasound, enabling planning and the monitoring of treatment of localized prostate cancer in realtime.
Sponsors
Association Francaise d'Urologie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General inclusion criteria * Patients with localized adenocarcinoma of the prostate classified as T1-2, N0, Nx M0 * classified as low or intermediate risk * Patient with PSA \< 15 ng/ml, Gleason score ≤ 7 restricted to the form \[3 + 4\]. * Biopsy with at least 12 specimens and a maximum of four out of six invaded sextants * Patient with a pelvic MRI if there is an intermediate risk and a bone scintigraphy if PSA \> 10 ng/ml * Patient affiliated with health insurance or beneficiary of an equivalent plan Inclusion criteria for the HIFU Arm * Patients 70 years of age or older * Patients with a life expectancy related to age and associated illness estimated to be greater than 5 years Inclusion Criteria for Total Prostatectomy Arm • Patients with a life expectancy greater than 10 years and a state of health allowing general anaesthesia. NON-INCLUSION CRITERIA * Patient participating in other biomedical research within 3 months prior to their inclusion in this protocol * Included patient simultaneously participating in another research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival | 30 months | The main objective for patients is to compare recurrence-free survival (i.e., the rate of salvage therapy by external beam radiotherapy and/or hormone therapy) in patients treated by HIFU and those treated by radical prostatectomy. The implementation of salvage therapy will be decided according to several non-exclusive criteria (positivity of margins (for patients with radical prostatectomy), PSA at 3 months, biologic recurrence (increase in PSA \> 0.2 ng/ml after radical surgery, \> Nadir +2 after HIFU), control biopsies positive, the appearance of metastases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| immediate or late complications | 3 months after treatment | clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...) |
| urinary function | Day 0, Inclusion | measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort |
| sexual fonction | Day 0, Inclusion | Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function |
| Immediate or late complications | 6 weeks after treatment | clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...) |
| The rate of patients in biochemical failure | 6 weeks after treatment | The rate of patients in biochemical failure is measured by PSA dosage: * PSA \> 0.2 ng for patients treated by radical surgery * PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU |
| The rate of local recurrence | 3 months after treatment | The rate of local recurrence is measured by control biopsy (number of positive biopsies) |
| Survival without metastases | 6 months after treatment | demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis. |
| Evaluation of quality of life | Day 0, Inclusion | Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent) |
Countries
France, Guadeloupe
Outcome results
None listed