3D Versus Robot Assisted Laparoscopic Prostatectomy.

3D Versus Robot Assisted Laparoscopic Prostatectomy. A Prospective Randomized Non-inferiority Study.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Radical prostatectomy

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 Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 34 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Robot assisted prostatectomy.; Intervention: radical prostatectomy	Procedure: Radical prostatectomy; Surgical removal of the prostate; Other Names: Total prostatectomy
Experimental: 3D laparoscopic prostatectomy; Intervention: radical prostatectomy	Procedure: Radical prostatectomy; Surgical removal of the prostate; Other Names: Total prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erectile function	International Index of Erectile Function (IIEF-5) Questionnaire score is used to quantify the return of erectile function post operatively.	12 months
Prostate specific antigen	Post operative prostate specific antigen levels.	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.	up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
costs of treatment	Direct and indirect treatment related costs.	12 months

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Seinajoki Central Hospital
• Investigators: Principal Investigator: Antti Kaipia, M.D., Ph.D., chief, dept of urology

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2018
• Primary Completion (Actual): July 30, 2021
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: radical prostatectomy; laparoscopic prostatectomy; robot assisted prostatectomy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 18005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient demographic, primary and secondary outcome measures available upon request.
• IPD Sharing Time Frame: 2020 onward for 5 years.
• IPD Sharing Access Criteria: IPD will be made for relevant high quality reseach uopn request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No