Prostate Cancer Clinical Trial
— LAP-01Official title:
A Multicenter Randomized Study to Investigate the Outcomes of Laparoscopic and Robotic-assisted Radical Prostatectomy
Verified date | September 2020 |
Source | University of Leipzig |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 782 |
Est. completion date | December 2021 |
Est. primary completion date | May 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum Dortmund | Dortmund | |
Germany | Universitätsklinikum Düsseldorf | Düsseldorf | |
Germany | University Hospital Heidelberg | Heidelberg | |
Germany | University of Leipzig | Leipzig |
Lead Sponsor | Collaborator |
---|---|
University of Leipzig | Heinrich-Heine University, Duesseldorf, Klinikum Dortmund, University Hospital Heidelberg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Continence | Continence (pad use/day) | 1, 3, 6, 12 months postoperative | |
Secondary | Continence | Continence (ICIQ-SF scores) | 1, 3, 6, 12 months postoperative | |
Secondary | Erectile function | Erectile function questionnaire (including IIEF-5 questionnaire) and information on supportive medication for erection | 1, 3, 6, 12 months postoperative | |
Secondary | 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. | 1, 3, 6, 12 months postoperative | |
Secondary | 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. | 1, 3, 6, 12 months postoperative | |
Secondary | Anxiety and depression assessment | The Hospital Anxiety and Depression Scales (HADS-D) | 1, 3, 6, 12 months postoperative | |
Secondary | 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. | 1, 3, 6, 12 months postoperative | |
Secondary | PSA (prostate-specific antigen) | PSA (prostate-specific antigen) | 1, 3, 6, 12, 24, 36 months postoperative | |
Secondary | Rate of relapse and metastases | Relapse and metastases | 1, 3, 6, 12, 24, 36 months postoperative | |
Secondary | Rate of patients with further anti-cancer therapy | Further anti-cancer therapy | 1, 3, 6, 12, 24, 36 months postoperative | |
Secondary | Time of surgery | time of surgery | measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console | |
Secondary | Tumor Resection | Tumor Resection | during surgery | |
Secondary | Intra-operative parameters | Rate of Complications | during surgery |
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