3D Versus Robot Assisted Laparoscopic Prostatectomy.

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03550040
• Other study ID #: 18005
• Status: Terminated
• Phase: N/A
• Start date: May 31, 2018
• Est. completion date: July 30, 2022

Study information

• Verified date: November 2023
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 155
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 34 Years to 74 Years

Eligibility

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Radical prostatectomy
Surgical removal of the prostate

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Seinajoki Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	costs of treatment	Direct and indirect treatment related costs.	12 months
Primary	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	Erectile function	International Index of Erectile Function (IIEF-5) Questionnaire score is used to quantify the return of erectile function post operatively.	12 months
Secondary	Prostate specific antigen	Post operative prostate specific antigen levels.	12 months
Secondary	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