Laparoscopic vs Robotic-Assisted Radical Prostatectomy
- Conditions
- Prostate Cancer
- Interventions
- Procedure: Prostatectomy
- Registration Number
- NCT03682146
- Lead Sponsor
- University of Leipzig
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 782
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LRP Prostatectomy conventional laparoscopic radical prostatectomy RARP Prostatectomy robot-assisted laparoscopic prostatectomy
- Primary Outcome Measures
Name Time Method Early Continence 3 months after removal of the urinary catheter The primary outcome is continence recovery at 3 months based on the patient's pad diary; RARP vs. LRP
- Secondary Outcome Measures
Name Time Method PSA (prostate-specific antigen) 1, 3, 6, 12, 24, 36 months postoperative PSA (prostate-specific antigen)
Intra-operative parameters during surgery Rate of Complications
Tumor Resection during surgery Tumor Resection
Prostate-specific quality of life of patients 1, 3, 6, 12 months postoperative 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.
Anxiety and depression assessment 1, 3, 6, 12 months postoperative The Hospital Anxiety and Depression Scales (HADS-D)
Rate of patients with further anti-cancer therapy 1, 3, 6, 12, 24, 36 months postoperative Further anti-cancer therapy
Continence 1, 3, 6, 12 months postoperative Continence (ICIQ-SF scores)
Erectile function 1, 3, 6, 12 months postoperative Erectile function questionnaire (including IIEF-5 questionnaire) and information on supportive medication for erection
Health-related quality of life of patients 1, 3, 6, 12 months postoperative 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.
Patient satisfaction 1, 3, 6, 12 months postoperative 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.
Rate of relapse and metastases 1, 3, 6, 12, 24, 36 months postoperative Relapse and metastases
Time of surgery measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console time of surgery
Trial Locations
- Locations (4)
Klinikum Dortmund
🇩🇪Dortmund, Germany
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
University of Leipzig
🇩🇪Leipzig, Germany
University Hospital Heidelberg
🇩🇪Heidelberg, Germany