Laparoscopic vs Robotic-Assisted Radical Prostatectomy
LAP-01
A Multicenter Randomized Study to Investigate the Outcomes of Laparoscopic and Robotic-assisted Radical Prostatectomy
2 other identifiers
interventional
782
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Nov 2014
Longer than P75 for not_applicable prostate-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 15, 2015
CompletedFirst Posted
Study publicly available on registry
September 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 30, 2023
September 1, 2020
6.5 years
May 15, 2015
November 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
Continence
1, 3, 6, 12 months postoperative
Continence
1, 3, 6, 12 months postoperative
Erectile function
1, 3, 6, 12 months postoperative
Health-related quality of life of patients
1, 3, 6, 12 months postoperative
Prostate-specific quality of life of patients
1, 3, 6, 12 months postoperative
- +8 more secondary outcomes
Study Arms (2)
RARP
OTHERrobot-assisted laparoscopic prostatectomy
LRP
OTHERconventional laparoscopic radical prostatectomy
Interventions
Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leipziglead
- Klinikum Dortmundcollaborator
- University Hospital Heidelbergcollaborator
- Heinrich-Heine University, Duesseldorfcollaborator
Study Sites (4)
Klinikum Dortmund
Dortmund, 44137, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
University Hospital Heidelberg
Heidelberg, 69120, Germany
University of Leipzig
Leipzig, 04103, Germany
Related Publications (3)
Holze S, Kuntze AS, Mende M, Neuhaus P, Truss MC, Do HM, Dietel A, Franz T, Stolzenburg JU. Assessment of different continence definitions in the context of the randomized multicenter prospective LAP-01 trial-Does the best definition change over time? Eur J Med Res. 2024 Jan 18;29(1):58. doi: 10.1186/s40001-024-01662-5.
PMID: 38238789DERIVEDHolze 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.
PMID: 35124734DERIVEDStolzenburg 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.
PMID: 33573861DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens-Uwe Stolzenburg, Prof.
Leipzig University, Department of Urology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Patients were blinded with respect to the surgical method until the end of the 3-month evaluation and extraction of the primary study outcome.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
May 15, 2015
First Posted
September 24, 2018
Study Start
November 1, 2014
Primary Completion
May 1, 2021
Study Completion
December 1, 2021
Last Updated
November 30, 2023
Record last verified: 2020-09