3D Versus Robot Assisted Laparoscopic Prostatectomy.

Tampere University Hospital

Status: Terminated

Conditions: Prostate Cancer

Treatments: Procedure: Radical prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03550040

18005

Details and patient eligibility

About

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

Full 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.

Enrollment: 155 patients

Sex: Male

Ages: 34 to 74 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 2 patient groups

Robot assisted prostatectomy.

Active Comparator group

Description:

Intervention: radical prostatectomy

Treatment:

Procedure: Radical prostatectomy

3D laparoscopic prostatectomy

Experimental group

Description:

Intervention: radical prostatectomy

Treatment:

Procedure: Radical prostatectomy