Prostate Cancer
Conditions
Keywords
radical prostatectomy, laparoscopic prostatectomy, robot assisted prostatectomy
Brief summary
A randomized, prospective study to compare the direct and indirect costs, functional and oncologic results of 3D laparoscopic and robot assisted radical prostatectomy procedures.
Detailed description
The direct and indirect costs, functional and oncologic results of robot assisted radical prostatectomy (RALP) are compared to those of 3D laparoscopic radical prostatectomy. The hypothesis of the study is that the functional and oncologic results of the two operative methods are equal, but the direct costs of RAPL are significantly higher. A randomized, prospective non-inferiority study will will enroll 280 patients randomized 1:1 to both operative approaches to test this hypothesis. The primary functional outcome measure is the proportion of patients with complete urinary continence (no protective pad use) at 12 months post operatively. Secondary functional outcome measure is the preservation erectile function at 12 months post operatively. Oncologic outcome measures are the proportion of patients with undetectable post operative prostate specific antigen levels and positive surgical margins at pathological examination. The direct and indirect costs of both operative approaches are recorded.
Interventions
PROCEDURERadical prostatectomy
Surgical removal of the prostate
Sponsors
Seinajoki Central Hospital
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective randomized study
Eligibility
Sex/Gender
MALE
Age
34 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Localized prostate cancer undergoing radical prostatectomy * Patient has to understand and be able to write and read Finnish language * No prior head injury, dementia or Parkinson's disease * No concomitant malignant illness * Life expectancy of at least 10 years * 35-74 years of age
Exclusion criteria
* Locally advanced prostate cancer (T4) * Suspicion or documented metastases (M1) * Serum PSA \> 20 ng/ml * Prior laparoscopic hernia surgery employing non resorbable mesh * Prior pelvic irradiation or major surgery * Prior malignant disease within prior 5 years excluding skin cancer (non-melanoma).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary continence | 12 months | Expanded Prostate Cancer Index Composite (EPIC) Short Form (EPIC-26), urinary domain score is used to assess the return of continence post operatively. The percentage of patients with no protective pad use at 12 months post operatively is the main outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prostate specific antigen | 12 months | Post operative prostate specific antigen levels. |
| Evaluation of surgical margins at pathologic examination. | up to 12 months | The oncological outcome is evaluated by the presence of cancerous tissue at the surgical margins of the specimen at pathologic examination. |
| Erectile function | 12 months | International Index of Erectile Function (IIEF-5) Questionnaire score is used to quantify the return of erectile function post operatively. |
Other
| Measure | Time frame | Description |
|---|---|---|
| costs of treatment | 12 months | Direct and indirect treatment related costs. |
Countries
Finland
Outcome results
None listed