Prostate Cancer
Conditions
Keywords
DaVinci, Robotic-Assisted, Prostatectomy, Laparoscopy, Continence
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.
Interventions
PROCEDUREProstatectomy
Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy
Sponsors
Klinikum Dortmund
University Hospital Heidelberg
Heinrich-Heine University, Duesseldorf
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients were blinded with respect to the surgical method until the end of the 3-month evaluation and extraction of the primary study outcome.
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Continence | 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
| Measure | Time frame | Description |
|---|---|---|
| Erectile function | 1, 3, 6, 12 months postoperative | Erectile function questionnaire (including IIEF-5 questionnaire) and information on supportive medication for erection |
| Health-related quality of life of patients | 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. |
| Prostate-specific quality of life of patients | 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. |
| Anxiety and depression assessment | 1, 3, 6, 12 months postoperative | The Hospital Anxiety and Depression Scales (HADS-D) |
| Patient satisfaction | 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. |
| Continence | 1, 3, 6, 12 months postoperative | Continence (pad use/day) |
| Rate of relapse and metastases | 1, 3, 6, 12, 24, 36 months postoperative | Relapse and metastases |
| Rate of patients with further anti-cancer therapy | 1, 3, 6, 12, 24, 36 months postoperative | Further anti-cancer therapy |
| Time of surgery | measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console | time of surgery |
| Tumor Resection | during surgery | Tumor Resection |
| Intra-operative parameters | during surgery | Rate of Complications |
| PSA (prostate-specific antigen) | 1, 3, 6, 12, 24, 36 months postoperative | PSA (prostate-specific antigen) |
Countries
Germany
Outcome results
None listed