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Completed

NCT Number: NCT03682146

Laparoscopic vs 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Dortmund, Dortmund, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostatectomy

Procedure

Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy

Other names: robotic-assisted laparoscopic radical prostatectomy, conventional laparoscopic radical prostatectomy

Primary outcomes

  1. Early Continence

    Time frame: 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 outcomes

  1. Continence

    Time frame: 1, 3, 6, 12 months postoperative

    Continence (pad use/day)

  2. Continence

    Time frame: 1, 3, 6, 12 months postoperative

    Continence (ICIQ-SF scores)

  3. Erectile function

    Time frame: 1, 3, 6, 12 months postoperative

    Erectile function questionnaire (including IIEF-5 questionnaire) and information on supportive medication for erection

  4. Health-related quality of life of patients

    Time frame: 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.

  5. Prostate-specific quality of life of patients

    Time frame: 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.

  6. Anxiety and depression assessment

    Time frame: 1, 3, 6, 12 months postoperative

    The Hospital Anxiety and Depression Scales (HADS-D)

  7. Patient satisfaction

    Time frame: 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.

  8. PSA (prostate-specific antigen)

    Time frame: 1, 3, 6, 12, 24, 36 months postoperative

    PSA (prostate-specific antigen)

  9. Rate of relapse and metastases

    Time frame: 1, 3, 6, 12, 24, 36 months postoperative

    Relapse and metastases

  10. Rate of patients with further anti-cancer therapy

    Time frame: 1, 3, 6, 12, 24, 36 months postoperative

    Further anti-cancer therapy

  11. Time of surgery

    Time frame: measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console

    time of surgery

  12. Tumor Resection

    Time frame: during surgery

    Tumor Resection

  13. Intra-operative parameters

    Time frame: during surgery

    Rate of Complications

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • Heinrich-Heine University, Duesseldorf
  • Klinikum Dortmund
  • University Hospital Heidelberg

Registry information

Official study title

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

Acronym: LAP-01

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Sep 24, 2018
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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