3D Versus Robot Assisted Laparoscopic Prostatectomy.

Not Applicable

Terminated

• Conditions: Prostate Cancer
• Interventions: Procedure: Radical prostatectomy

• Registration Number: NCT03550040
• Lead Sponsor: Tampere University Hospital

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.

Study Timeline

• Study First Submitted: 2018-05-14
• Study Start: 2018-05-31
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-08
• Primary Completion: 2021-07-30
• Study Completion: 2022-07-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 155

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot assisted prostatectomy.	Radical prostatectomy	Intervention: radical prostatectomy
3D laparoscopic prostatectomy	Radical prostatectomy	Intervention: radical prostatectomy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland