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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
782
Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy
Klinikum Dortmund
Dortmund, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
University Hospital Heidelberg
Heidelberg, Germany
University of Leipzig
Leipzig, Germany
Early Continence
The primary outcome is continence recovery at 3 months based on the patient's pad diary; RARP vs. LRP
Time frame: 3 months after removal of the urinary catheter
Continence
Continence (pad use/day)
Time frame: 1, 3, 6, 12 months postoperative
Continence
Continence (ICIQ-SF scores)
Time frame: 1, 3, 6, 12 months postoperative
Erectile function
Erectile function questionnaire (including IIEF-5 questionnaire) and information on supportive medication for erection
Time frame: 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.
Time frame: 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.
Time frame: 1, 3, 6, 12 months postoperative
Anxiety and depression assessment
The Hospital Anxiety and Depression Scales (HADS-D)
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Time frame: 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.
Time frame: 1, 3, 6, 12 months postoperative
PSA (prostate-specific antigen)
PSA (prostate-specific antigen)
Time frame: 1, 3, 6, 12, 24, 36 months postoperative
Rate of relapse and metastases
Relapse and metastases
Time frame: 1, 3, 6, 12, 24, 36 months postoperative
Rate of patients with further anti-cancer therapy
Further anti-cancer therapy
Time frame: 1, 3, 6, 12, 24, 36 months postoperative
Time of surgery
time of surgery
Time frame: measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console
Tumor Resection
Tumor Resection
Time frame: during surgery
Intra-operative parameters
Rate of Complications
Time frame: during surgery