Prostate Cancer
Conditions
Keywords
Clinically localized prostate cancer, Robotic-assisted prostatectomy, Laparoscopic prostatectomy, Erectile function ;, Cost efficacy study
Brief summary
In this observational cost efficacy study, the investigator compare the Laparoscopic Radical Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of care that include hospitalization related or post operative medical consumption are obtained and recorded up to 5 years follow up. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Carcinologic results are estimated by Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be made to estimate direct costs of the four postoperative year along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary continence and erectile function and PSA \< 0.2).
Interventions
PROCEDURERobotic-Assisted Radical Prostatectomy
PROCEDURELaparoscopic Radical Prostatectomy
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Localized prostate cancer * Gleason grade ≤ 3 + 4 * PSA \< 15 ng / mL * Stage ≤ T2b * Eligible to receive laparoscopic radical prostatectomy * Candidate bilateral or unilateral erectile preservation
Exclusion criteria
* Patient at high risk of postoperative progression (PSA\> 15 ng / mL; grade 5 predominant, clinical or radiological stage T3 * Presenting erectile dysfunction (IIEF \< 22) * Past history of urinary incontinence (\> grade 1 WHO) * Body mass index \> 30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erectile function | 12 months after surgery | Proportion of patients with recovery of erectile function between T0 (before surgery) and 12 months after surgery. Recovery is defined as a maximum decrease of 5 points score of the International Index of Erectile Function (IIEF) between pre and postoperative evaluations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Specific Antigen (PSA) | Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery | — |
| Continence | Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12), 24 months (M24) and 60 months (M60) after surgery | Continence is assessed by the International Prostate Symptom Score (IPSS) |
| Surgical margins | During surgery | — |
| Quality of life | Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12) and 24 months (M24) after surgery | Quality of life is assessed by EQ-5D, QLQ-C30 and QLQ-PR25 scores |
| Incremental cost-effectiveness ratio | 60 months afet surgery | Economic evaluation will be made to estimate direct costs of the five postoperative years along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment |
| Tolerance | Perioperative period, 6 months (M6), 12 months (M12) and 24 months (M24) afer surgery | Adverse events related to the perioperative prostatectomy, 6 months, 12 months and 24 months afer surgery |
Countries
France
Outcome results
None listed