Laparoscopic vs Robotic-Assisted Radical Prostatectomy (LAP-01)

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Prostatectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 782
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sigrun Holze, PhD; Email: LAP-01@uniklinik-leipzig.de

Study Locations

• Germany
  • Dortmund, Germany, 44137
    • Klinikum Dortmund
  • Düsseldorf, Germany, 40225
    • Universitatsklinikum Dusseldorf
  • Heidelberg, Germany, 69120
    • University Hospital Heidelberg
  • Leipzig, Germany, 04103
    • University of Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: RARP; robot-assisted laparoscopic prostatectomy	Procedure: Prostatectomy; Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy; Other Names: conventional laparoscopic radical prostatectomy; robotic-assisted laparoscopic radical prostatectomy
Other: LRP; conventional laparoscopic radical prostatectomy	Procedure: Prostatectomy; Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy; Other Names: conventional laparoscopic radical prostatectomy; robotic-assisted laparoscopic radical prostatectomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Leipzig
• Collaborators: Heinrich-Heine University, Duesseldorf; University Hospital Heidelberg; Klinikum Dortmund
• Investigators: Principal Investigator: Jens-Uwe Stolzenburg, Prof., Leipzig University, Department of Urology

Publications and helpful links

General Publications

• Holze S, Braunlich M, Mende M, Arthanareeswaran VK, Neuhaus P, Truss MC, Do HM, Dietel A, Franz T, Teber D, Heilsberg AK, Hohenfellner M, Rabenalt R, Albers P, Stolzenburg JU. Age-stratified outcomes after radical prostatectomy in a randomized setting (LAP-01): do younger patients have more to lose? World J Urol. 2022 May;40(5):1151-1158. doi: 10.1007/s00345-022-03945-0. Epub 2022 Feb 6.
• Stolzenburg JU, Holze S, Neuhaus P, Kyriazis I, Do HM, Dietel A, Truss MC, Grzella CI, Teber D, Hohenfellner M, Rabenalt R, Albers P, Mende M. Robotic-assisted Versus Laparoscopic Surgery: Outcomes from the First Multicentre, Randomised, Patient-blinded Controlled Trial in Radical Prostatectomy (LAP-01). Eur Urol. 2021 Jun;79(6):750-759. doi: 10.1016/j.eururo.2021.01.030. Epub 2021 Feb 9.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: May 15, 2015
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Robotic-Assisted; Prostatectomy; Laparoscopy; Continence; DaVinci
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: LAP-01; 110462 (Other Grant/Funding Number: Deutsche Krebshilfe)