Radical prostatectomy with or without lymph node removal
Summary description of the study
The current standard for surgical removal of the prostate is the simultaneous removal of pelvic lymph nodes if there is an increased risk of cancer spread to the lymph nodes. However, it is still unclear whether the removal of pelvic lymph nodes actually provides an advantage regarding the course of the cancer disease. Additionally, the removal of pelvic lymph nodes prolongs the operation time by about one hour and is associated with more complications. In this study, we investigate whether the removal of pelvic lymph nodes affects the development of the disease.
(BASEC)
Intervention under investigation
radical prostatectomy with/without lymph node removal
(BASEC)
Disease under investigation
Prostate cancer
(BASEC)
Any biopsy-proven WHO/ISUP grade groups III-V PCa ISUP grade group II and PSA > 20 ng/ml Any cT3 (MRI) PSMA-PET: negative staging for regional and distant metastasis WHO performance status 0-1 (BASEC)
Exclusion criteria
ISUP grade group I PCa and cT1 or cT2 (MRI) cT4 (MRI) PCa PSMA-PET: positive staging for local and distant metastases Any prior neoadjuvant, local or systemic treatment for PCa Previous PLND or pelvic radiotherapy (BASEC)
Trial sites
Basel
(BASEC)
Sponsor
USB
(BASEC)
Contact
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
03.01.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Dissection 2.0 (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available