3D Versus Robot Assisted Laparoscopic Prostatectomy.

Tampere University Hospital155 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

155

Conditions

Prostate Cancer

Interventions

Radical prostatectomyPROCEDURE

Surgical removal of the prostate

Eligibility

Sex: MALEMin age: 34 YearsMax age: 74 Years

Medical Language ↔ Plain English

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).

Locations (1)

Tampere University Hospital

Tampere, Finland

Outcomes

Primary Outcomes

Urinary continence

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.

Time frame: 12 months

Secondary Outcomes

Erectile function

International Index of Erectile Function (IIEF-5) Questionnaire score is used to quantify the return of erectile function post operatively.

Time frame: 12 months

Prostate specific antigen

Post operative prostate specific antigen levels.

Time frame: 12 months

Evaluation of surgical margins at pathologic examination.

The oncological outcome is evaluated by the presence of cancerous tissue at the surgical margins of the specimen at pathologic examination.

Time frame: up to 12 months

Data from ClinicalTrials.gov

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