Laparoscopic vs Robotic-Assisted Radical Prostatectomy (NCT03682146) | Clinical Trial Compass
CompletedNot Applicable
Laparoscopic vs Robotic-Assisted Radical Prostatectomy
Germany782 participantsStarted 2014-11
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early Continence
Timeframe: 3 months after removal of the urinary catheter