Prostate CancerLAP-01NCT03682146
Laparoscopic vs Robotic-Assisted Radical Prostatectomy
A study testing Prostatectomy in people with Prostate Cancer, run by University of Leipzig at 4 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 782 participants
- Where
- 4 sitesGermany
- Study dates
- Nov 2014to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Klinikum Dortmund
Dortmund, 44137
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
University Hospital Heidelberg
Heidelberg, 69120
University of Leipzig
Leipzig, 04103
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Prostatectomy
- Keywords
- DaVinci, Robotic-Assisted, Prostatectomy, Laparoscopy, Continence
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProstatectomyProcedure or surgery
Also called robotic-assisted laparoscopic radical prostatectomy, conventional laparoscopic radical prostatectomy
Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| RARP | Other | robot-assisted laparoscopic prostatectomy Receives: Procedure: Prostatectomy |
| LRP | Other | conventional laparoscopic radical prostatectomy Receives: Procedure: Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Continence
The primary outcome is continence recovery at 3 months based on the patient's pad diary; RARP vs. LRP
Measured: 3 months after removal of the urinary catheter
Secondary outcomes (13)
Continence
Continence (pad use/day)
Measured: 1, 3, 6, 12 months postoperative
Continence
Continence (ICIQ-SF scores)
Measured: 1, 3, 6, 12 months postoperative
Erectile function
Erectile function questionnaire (including IIEF-5 questionnaire) and information on supportive medication for erection
Measured: 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.
Measured: 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.
Measured: 1, 3, 6, 12 months postoperative
Anxiety and depression assessment
The Hospital Anxiety and Depression Scales (HADS-D)
Measured: 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.
Measured: 1, 3, 6, 12 months postoperative
PSA (prostate-specific antigen)
PSA (prostate-specific antigen)
Measured: 1, 3, 6, 12, 24, 36 months postoperative
Rate of relapse and metastases
Relapse and metastases
Measured: 1, 3, 6, 12, 24, 36 months postoperative
Rate of patients with further anti-cancer therapy
Further anti-cancer therapy
Measured: 1, 3, 6, 12, 24, 36 months postoperative
Time of surgery
time of surgery
Measured: measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console
Tumor Resection
Tumor Resection
Measured: during surgery
Intra-operative parameters
Rate of Complications
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study startNov 2014
- Primary completionMay 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 782 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Dortmund, University Hospital Heidelberg, Heinrich-Heine University, Duesseldorf
- Responsible party
- Principal investigator, Jens-Uwe Stolzenburg, University of Leipzig
- Investigators
- Jens-Uwe Stolzenburg, Prof., Principal investigator, Leipzig University, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682146
- Sponsor's protocol ID
- LAP-01
- Other IDs
- 110462
- Acronym
- LAP-01
- Status last verified
- Sep 2020
- First submitted
- 15 May 2015
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38238789Holze 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.
PubMed 35124734Stolzenburg 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.
PubMed 33573861
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Study to Investigate the Outcomes of Laparoscopic and Robotic-assisted Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03682146
- Acronym / sponsor ID
- LAP-01 / LAP-01
- Conditions
- Prostate Cancer
- Keywords
- DaVinci, Robotic-Assisted, Prostatectomy, Laparoscopy, Continence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 782 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Klinikum Dortmund, University Hospital Heidelberg, Heinrich-Heine University, Duesseldorf
- Study start
- Nov 2014 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RARP | Other | Procedure: Prostatectomyrobot-assisted laparoscopic prostatectomy |
| LRP | Other | Procedure: Prostatectomyconventional laparoscopic radical prostatectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProstatectomyAlso: robotic-assisted laparoscopic radical prostatectomy, conventional laparoscopic radical prostatectomyComparison of robotic-assisted and conventional laparoscopic radical prostatectomy | Procedure or surgery | LRP, RARP |
Primary outcome
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
13 secondary outcomes
Continence
Time frame: 1, 3, 6, 12 months postoperative
Continence
Time frame: 1, 3, 6, 12 months postoperative
Erectile function
Time frame: 1, 3, 6, 12 months postoperative
Health-related quality of life of patients
Time frame: 1, 3, 6, 12 months postoperative
Prostate-specific quality of life of patients
Time frame: 1, 3, 6, 12 months postoperative
Anxiety and depression assessment
Time frame: 1, 3, 6, 12 months postoperative
Patient satisfaction
Time frame: 1, 3, 6, 12 months postoperative
PSA (prostate-specific antigen)
Time frame: 1, 3, 6, 12, 24, 36 months postoperative
Rate of relapse and metastases
Time frame: 1, 3, 6, 12, 24, 36 months postoperative
Rate of patients with further anti-cancer therapy
Time frame: 1, 3, 6, 12, 24, 36 months postoperative
Time of surgery
Time frame: measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console
Tumor Resection
Time frame: during surgery
Intra-operative parameters
Time frame: during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Derived from this study: PubMed 38238789Holze 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.
- Derived from this study: PubMed 35124734Holze 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.
- Derived from this study: PubMed 33573861Stolzenburg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens-Uwe Stolzenburg, Prof. principal investigator
Leipzig University, Department of Urology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostatectomy in people with Prostate Cancer, run by University of Leipzig at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Continence (time frame: 3 months after removal of the urinary catheter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682146, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.