accrual was sufficient at interim analysis to draw final conclusions needed to publish

A randomized, prospective study to compare the direct and indirect costs, functional and oncologic results of 3D laparoscopic and robot assisted radical prostatectomy procedures.

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.

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).

Patient demographic, primary and secondary outcome measures available upon request.

2020 onward for 5 years.

IPD will be made for relevant high quality reseach uopn request.