3D Versus Robot Assisted Laparoscopic Prostatectomy.

NCT03550040 | Terminated

• 1 other identifier: 18005
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

radical prostatectomy; laparoscopic prostatectomy; robot assisted prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Erectile function

  12 months

• Prostate specific antigen

  12 months

• Evaluation of surgical margins at pathologic examination.

  up to 12 months

Other Outcomes (1)

• costs of treatment

  12 months

Study Arms (2)

Robot assisted prostatectomy.

ACTIVE COMPARATOR

Intervention: radical prostatectomy

Procedure: Radical prostatectomy

3D laparoscopic prostatectomy

EXPERIMENTAL

Intervention: radical prostatectomy

Procedure: Radical prostatectomy

Interventions

Radical prostatectomy PROCEDURE

Surgical removal of the prostate

Also known as: Total prostatectomy

3D laparoscopic prostatectomy; Robot assisted prostatectomy.

Eligibility Criteria

• Age: 34 Years - 74 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tampere University Hospital: lead
• Seinajoki Central Hospital: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Antti Kaipia, M.D., Ph.D.

  chief, dept of urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, department of urology

Model Details: Prospective randomized study

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: June 8, 2018
• Study Start: May 31, 2018
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2022
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2020 onward for 5 years.
• Access Criteria: IPD will be made for relevant high quality reseach uopn request.

Locations

FI (1)