Prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
Initial information at time of registration:
Group A: Traditional radical prostatectomy by open surgical approach
Group B: Radical prostatectomy by robot-assisted laparoscopic approach
In both grou
Sponsors
Sahlgrenska University Hospital (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current information as of 02/09/2009: 1. Men with localised prostate cancer, stage T1-T3 2. No signs of distant metastases, i.e. stage M0 3. Prostate-Specific Antigen (PSA) =7 2. PSA <15
Exclusion criteria
Exclusion criteria: Current information as of 02/09/2009: History of earlier/other cancer (does not include basal cell cancer) Initial information at time of registration: 1. Body Mass Index (BMI) >35 2. History of earlier/other cancer (does not include basal cell cancer) 3. Men with prostate cancer stage =T3 4. Distant metastases 5. PSA >20 6. Patient not suitable for laparoscopic operation 7. Age >75 years 8. Concerning the randomised study of regional lymph node dissection: 8.1. Gleason <7 och/eller 8.2. PSA =15
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erectile dysfunction and urinary leakage within 24 months of radical prostatectomy. The evaluation of these symptoms will be through detailed self evaluation questionnaires, specifically constructed and validated for this population. The questionnaires will be answered before and 3, 12 and 24 months after the operation. Similar techniques have been used before in a large Swedish randomised trial comparing open radical prostatectomy to 'watchful waiting' in early prostate cancer. Added 11/05/2010: Urinary leakage as registered 12 months postoperatively. Added 04/01/2011: The definition of urinary incontinence used for the interim analysis was incontinence = change of pad/equivalent once daily or more. This definition will be used for the analysis of the primary end-point incontinence 12 months postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Radicality as judged by the pathology report of the operation specimen. The report will be stratified for all including hospitals including pT stage, growth in resection line, N-stage and Gleason score 2. Oncological result judged by PSA relapse, defined as a PSA >0.2 to be determined at 3, 12 and 24 months after the operation 3. Operating time 4. Blood transfusions 5. Re-operations 6. Length of hospital stay 7. Re-admittance 8. Length of sick leave 9. Length of catheter treatment 10. Continued urinary leakage and erectile dysfunction 11. Inguinal hernia 12. Short term complications of any kind 13. Mortality and complications within 3 months, due to regional lymph node dissections 14. Self evaluated health related quality of life using a specifically constructed instrument, based on questionnaire used for the primary outcome measure. The instrument has been re-validated after revision. 15. Health economy analyses, based on variables described above and also including Quality-Adjusted Life Year (QALY) using the EuroQol (EQ-5D) instrument, at 3, 12 and 24 months 16. Long-term survival through Swedish Cancer Registry Added 03/11/2009: 17. Learning curve and factors that influence learning of the surgical technique 18. An analysis will be performed of 'intrusive thoughts' in relation to health-related quality of life before and 3 months postoperatively for the patient population accrued by October 2009. The analyses will not include any information about the intervention group for the individual patients and thus no connection to treatment group will be made. The analyses will be made before full accrual has been reached. Added 11/05/2010: Some data from the database for the entire population (defined as those included over the initial 12 months of the trial inclusion period) will be used to analyse some confounding factors. Data will not be retrieved by interventional group, but only for the entire population. These analyses will be made during 201 | — |
Countries
Sweden
Outcome results
None listed