Prostate Cancer
Conditions
Keywords
Localized Prostate cancer, Prostatectomy, Focal HIFU, Quality of life, Cost, ISUP 2
Brief summary
Medico-Economic Randomized Trial comparing Focal HIFU Treatment to Radical Prostatectomy in Patients with Favorable Intermediate Risk Prostate Cancer
Detailed description
Standard treatment option of intermediate risk (ISUP2) prostate cancer (PC) is either radical prostatectomy (RP) or radiation therapy (RT). An attractive option for selected patients and for the health care system would be to spare the preserved gland to decrease urinary, sexual and digestive side effects of whole-gland treatments keeping with a good cancer control. For these reasons, focal treatments have been developed in localized PC. The principal objective of the EMERHIT study is to estimate, from the health system point of view, the efficiency (cost/utility study) of focal HIFU (F-HIFU) for intermediate risk PC compared to RP (either by open, laparoscopic or robotic surgical approach) at 24 months. It will be a multicentric pragmatic clinical trial, comparative, with no insu, randomized in two parallel groups : * (1) F-HIFU treatment * (2) RP Randomization will be equal (ratio 1:1), stratified on the centers and performed maximum at 2 months before the procedure. The comparison to the SNDS data will use the NIR of the patients selected for the study. The use of the SNDS data will allow, on top of the estimation of the care cost, to increase the patient's follow-up (with no supplemental visit) and measure, at 48 months, costs, mortality rate and cancer control measures From version 4.0 of the protocol, randomisation will be adjusted to a 2:1 ratio and stratified by centre.
Interventions
DEVICEF-HIFU
A F-HIFU treatment will be performed with the Focal-One® machine according to the predefined treatment area for each patient using the standard procedure in place in each therapeutic center and according to the user's manual edited by the company, under locoregional or general anaesthesia.
PROCEDURERadical Prostatectomy
A Radical Prostatectomy will be performed according to the standard procedure in place in each center, under general anaesthesia, through an open, laparoscopic or robot-assisted laparoscopic approach
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Multicentric pragmatic clinical trial, comparative, with no insu, randomized in two parallel groups with a 1:1 allocation ratio
Eligibility
Sex/Gender
MALE
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 45-75 yo male harboring a non-treated localized prostatic adenocarcinoma of maximum Gleason score 3+4, ISUP 2 unilateral on at most maximum 2 contiguous sextants (favorable intermediate risk),with or without ipsilateral or contralateral focus of score 3+3 (ISUP1). * Tumor visible on MRI and proven by systematic and/or targeted biopsies according to the center's practices, regardless of the route used (transrectal or transpirenal) * Or patients under active surveillance whose follow-up prostate biopsies reveal unilateral ISUP2 on at most 2 contiguous sextants (favorable intermediate risk), with or without ipsilateral or contralateral Gleason 3+3 focus (ISUP1) * Patients with several suspicious foci on MRI may be be included if only one of these foci is confirmed by targeted biopsies with an ISUP2 score. If more than one suspected site on MRI is confirmed by targeted biopsies, these should be unilateral ISUP2 on a maximum of 2 contiguous sextants (favourable intermediate risk), with or without an ipsilateral or contralateral site with a Gleason score of 3+3 (ISUP1). * stage T1c-T2, * with PSA \<20 ng/ml, * with prostate volume less than 150 ml, * patient clearly informed of the study and having agreed, with sufficient time for reflection to participate by signing the study's informed consent form, * patient affiliated to or benefiting from a social security scheme
Exclusion criteria
* Metastatic prostate cancer. * Gleason score \> 3+4 (ISUP\>2). * Adenoma prostate carcinoma Cribriform or intraductal. * Previous treatment anterior for the same cancer, whatever modality. * Contra-indication to pelvic MRI with gadolinium injection. * Contra-indication to surgery or general anesthesia. * Patient who refuse the one-year follow-up control biopsy after F-HIFU. * Presence of implant (stent, catheter) less than 1 cm from the treatment area. * Urinary or rectal fistula. * Anal or rectal stenosis or any other abnormality that may interfere with the Focal One® endorectal probe introduction. * Anatomic abnormality of the rectum or rectal mucosa. * Presence of a urinary artificial sphincter, a penile prosthesis or intraprostatic implant, i.e. urethral prosthesis. * Bladder neck and/or urethral stenosis or sclerosis. * Inflammatory bowel disease (colon or rectum). * Ongoing UTI (should be treated before the F-HIFU or the RP). * Previous anal or rectal surgery that may interfere with the anal probe introduction. * Latex allergy. * Rectal wall thickness \> 10 mm. * Tumor not accessible to a F-HIFU treatment (tumors located in the fibro-muscular anterior zone). * Previous not controlled cancer and/or treated since less than 5 years (except basocellular skin cancer). * Patient not able to understand the trial objectives or refusing to adhere to the trial instructions. * Patients under law-protection. * Patient in an ongoing research trial. * Patient with a severe health or psychologic problem that could impair the protocol pathway.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The cost/utility ratio expressed as differential cost per QALY in favor of F-HIFU compared to RP (open, lap or robot) at 24 months. | 24 months | Utility will be measured at baseline and at 6, 12 and 24 months using the EQ-5D-5L self-administered questionnaire. Costs will be estimated from the perspective of the French health system. They will be collected by probabilistic matching with data from the SNDS using data from the inclusion hospitalization of each patient included in the the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The per-year of preserved life differential cost between F-HIFU and RP | 48 months | The per-year of preserved life differential cost at 48 months between F-HIFU and RP from the SNDS database evaluated by micro-costing |
| Differential cost between F-HIFU and open, lap or robotic RP | 24 months | Differential cost of per-QALY improved at 24 months between F-HIFU and open, lap or robotic RP evaluated by micro-costing |
| Real production cost (€) of F-HIFU and RP | 48 months | Real production cost (€) of F-HIFU and RP evaluated by micro-costing |
| Net benefit (€) for the Health Insurance | 48 months | Net benefit (€) for the Health Insurance of a diffusion of F-HIFU into the French Health System for patients with favorable intermediate risk PC evaluated by micro-costing |
| Survival with no salvage treatmente. | 12, 24 and 48 months | Survival with no salvage treatment at 12, 24 and 48 months, evaluated in part from the SNDS database. Optional salvage treatments possibly being: a second F-HIFU, RP or radiotherapy with or without androgen deprivation. All salvage treatments, except the F-HIFU, are already reimbursed by the French Health System and available in the SNDS database. |
| Overall survival | 12, 24 and 48 months | Overall survival at 12, 24 and 48 months measured from the inclusion date to the date of death, all causes of death being included or the date of the last visit or at 48 months |
| Cancer specific survival | 12, 24 and 48 months | Cancer specific survival at 12, 24 and 48 month measured from the date of inclusion to the date of death due to the progression of PC or the date of the last visit. Causes of death are available in the SNDS database since it is implemented by the CEpiDC |
| Androgen deprivation-free survival | 12, 24 and 48 months | Androgen deprivation-free survival (equivalent to metastasis-free survival) at 12, 24 and 48 month measured from the inclusion date to the first prescription of androgen deprivation therapy or the date of the last visit |
| Urinary and sexual functions | Inclusion and 1, 6, 12 and 24 months | Urinary and sexual functions will be evaluated at inclusion then at 6, 12 and, 24 month using auto-questionnaires EPIC-26 |
| Patient's quality of life | Inclusion and 1, 6, 12 and 24 months | Patient's quality of life will be evaluated at inclusion then at 6, 12 and 24 month using the auto-questionnaires EORTC QLQ C30 |
Countries
France, Guadeloupe
Contacts
CONTACTFranck BLADOU, PROF
CONTACTGrégoire ROBERT, PROF
PRINCIPAL_INVESTIGATORFranck BLADOU, PROF
University Hospital, Bordeaux
Outcome results
None listed