Laparoscopic vs Robotic-Assisted Radical Prostatectomy

Study Overview
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Brief Summary
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This randomized trial was designed to address the lack of high-quality literature comparing robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy (RP). Purpose: The LAP-01 trial compares outcomes between RARP and LRP.

Detailed Description
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LAP-01 is the first multicenter, prospective randomized, patient-blinded controlled trial comparing robotic-assisted and conventional laparoscopic radical prostatectomy. The investigation include an extensive evaluation of clinical, oncological, functional and quality of life related data by means of validated patient-reported outcome measures. The primary outcome is the assessment of time to continence restoration at 3 months. This is evaluated by an assessment of a pad diary completed daily by each patient from the time of catheter removal until restoration of continence. Secondary endpoints include continence and erectile function, as well as quality of life (EORTC-QLQ-C30, EORTC-QLQ-PR25), patient satisfaction and Hospital Anxiety and Depression Scale (HADS) at 1, 3, 6 and 12 months after surgery in addition to oncological outcomes up to 3 years follow-up. With 782 enrolled patients it is the largest trial carried out till date on this topic.

Official Title
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A Multicenter Randomized Study to Investigate the Outcomes of Laparoscopic and Robotic-assisted Radical Prostatectomy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Prostatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Histological verified prostate carcinoma (first diagnosis) Indication for primary curative radical prostatectomy Age ≤ 75 years Patient agrees to randomisation Patient is able to fill in the questionnaires on his own Patient is willing to provide written informed consent Exclusion Criteria: Insufficient knowledge of German Severe cognitive impairment Obesity (BMI > 35) Current existing severe comorbidities (e.g. liver cirrhosis, second malignancy or relapse of every kind) Tumor stage: T4 Previous malignancy (≤ 3 years before trial participation) Neoadjuvant therapy (hormons) within the last 3 months before participation in the trial Patient is immuno-compromised History of intermittent urinary self-catheterization within the last year Psychological disorders (dementia, chronic depression, psychosis) Any of the following treatments ≤ 3 months before trial participation: surgery of the sigmoid colon, extended haemorrhoid resection, transurethral needle ablation of the prostate (TUNA), osteosynthesis of the pelvis, salvage prostatectomy Patients with chronic urinary infection Dialysis patients Lacking willingness for data storage and handling in the frame of the trial protocol/aims

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RARP<br>robot-assisted laparoscopic prostatectomy | Procedure: Prostatectomy<br>* Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy<br>* Other names: conventional laparoscopic radical prostatectomy;|
| Other: LRP<br>conventional laparoscopic radical prostatectomy | Procedure: Prostatectomy<br>* Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy<br>* Other names: conventional laparoscopic radical prostatectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Continence | The primary outcome is continence recovery at 3 months based on the patient's pad diary; RARP vs. LRP | 3 months after removal of the urinary catheter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continence | Continence (pad use/day) | 1, 3, 6, 12 months postoperative | 
| Continence | Continence (ICIQ-SF scores) | 1, 3, 6, 12 months postoperative | 
| Erectile function | Erectile function questionnaire (including IIEF-5 questionnaire) and information on supportive medication for erection | 1, 3, 6, 12 months postoperative | 
| Health-related quality of life of patients | Health-related quality of life questionnaire (EORTC QLQ-C30). Raw scores are linearly transformed into a 0-100 point scale. High global health status and functioning scores indicate good QoL, whereas elevated symptom scores represent a high level of symptomology and therefore impaired QoL. | 1, 3, 6, 12 months postoperative | 
| Prostate-specific quality of life of patients | Prostate-specific quality of life questionnaire (EORTC QLQ-PR25). Raw scores are linearly transformed into a 0-100 point scale. High functioning scores indicate good QoL, whereas elevated symptom scores represent a high level of symptomology and therefore impaired QoL. | 1, 3, 6, 12 months postoperative | 
| Anxiety and depression assessment | The Hospital Anxiety and Depression Scales (HADS-D) | 1, 3, 6, 12 months postoperative | 
| Patient satisfaction | Patient satisfaction is measured on a 5-point scale ranging from highly dissatisfied to highly satisfied. Additionally, patients are asked if they would in hindsight make a decision for or against the surgery and if they would advise a friend to undergo surgery under the same circumstances. | 1, 3, 6, 12 months postoperative | 
| PSA (prostate-specific antigen) | PSA (prostate-specific antigen) | 1, 3, 6, 12, 24, 36 months postoperative | 
| Rate of relapse and metastases | Relapse and metastases | 1, 3, 6, 12, 24, 36 months postoperative | 
| Rate of patients with further anti-cancer therapy | Further anti-cancer therapy | 1, 3, 6, 12, 24, 36 months postoperative | 
| Time of surgery | time of surgery | measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console | 
| Tumor Resection | Tumor Resection | during surgery | 
| Intra-operative parameters | Rate of Complications | during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DaVinci, Robotic-Assisted, Prostatectomy, Laparoscopy, Continence