Clinical trial NCT03682146: Laparoscopic vs Robotic-Assisted Radical Prostatectomy
Official title: A Multicenter Randomized Study to Investigate the Outcomes of Laparoscopic and Robotic-assisted Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: DaVinci
Robotic-Assisted
Prostatectomy
Laparoscopy
Continence
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Klinikum Dortmund
name: University Hospital Heidelberg
name: Heinrich-Heine University, Duesseldorf
First posted: 2018-09-24
Enrollment: 782
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Early Continence
timeFrame: 3 months after removal of the urinary catheter
Secondary outcomes:
measure: Continence
timeFrame: 1, 3, 6, 12 months postoperative
measure: Continence
timeFrame: 1, 3, 6, 12 months postoperative
measure: Erectile function
timeFrame: 1, 3, 6, 12 months postoperative
measure: Health-related quality of life of patients
timeFrame: 1, 3, 6, 12 months postoperative
measure: Prostate-specific quality of life of patients
timeFrame: 1, 3, 6, 12 months postoperative
measure: Anxiety and depression assessment
timeFrame: 1, 3, 6, 12 months postoperative
measure: Patient satisfaction
timeFrame: 1, 3, 6, 12 months postoperative
measure: PSA (prostate-specific antigen)
timeFrame: 1, 3, 6, 12, 24, 36 months postoperative
measure: Rate of relapse and metastases
timeFrame: 1, 3, 6, 12, 24, 36 months postoperative
measure: Rate of patients with further anti-cancer therapy
timeFrame: 1, 3, 6, 12, 24, 36 months postoperative
measure: Time of surgery
timeFrame: measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console
measure: Tumor Resection
timeFrame: during surgery
measure: Intra-operative parameters
timeFrame: during surgery
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Leipzig
country: Germany
facility: University of Leipzig
Study officials:
affiliation: Leipzig University, Department of Urology
name: Jens-Uwe Stolzenburg, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.