Clinical trial NCT03550040: 3D Versus Robot Assisted Laparoscopic Prostatectomy.
Official title: 3D Versus Robot Assisted Laparoscopic Prostatectomy. A Prospective Randomized Non-inferiority Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: radical prostatectomy
laparoscopic prostatectomy
robot assisted prostatectomy
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Seinajoki Central Hospital
First posted: 2018-06-08
Enrollment: 155
Sex: MALE
Minimum age (years): 34
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Urinary continence
timeFrame: 12 months
Secondary outcomes:
measure: Erectile function
timeFrame: 12 months
measure: Prostate specific antigen
timeFrame: 12 months
measure: Evaluation of surgical margins at pathologic examination.
timeFrame: up to 12 months
Other outcomes:
measure: costs of treatment
timeFrame: 12 months
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: chief, dept of urology
name: Antti Kaipia, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: