Extended Pelvic Lymph Node Dissection vs. No Pelvic Lymph Node Dissection at Radical Prostatectomy in PSMA PET Negative Staged Men: A Multicenter, Randomized Phase III Trial
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The aim of the DISSECTION 2.0 study is to determine whether extended pelvic lymph node dissection (ePLND) provides a therapeutic benefit for high-risk prostate cancer patients by improving cancer staging and potentially removing micrometastatic disease, ultimately improving their outcomes.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years and life expectancy \>15 years
• Any biopsy-proven WHO/ISUP grade groups III-V PCa
• High-risk prostate cancer defined as:
‣ Any biopsy-proven WHO/ISUP grade group III-V PCa or
⁃ ISUP grade group II and PSA \> 20 ng/ml
• PSMA-PET: negative staging for regional and distant metastasis
• multidisciplinary tumorboard recommendation for radical prostatectomy
• WHO performance status 0-1
• Adequate condition (ASA ≤ III) for general anesthesia and RP
Locations
Other Locations
Switzerland
Cantonal Hospital Aarau
RECRUITING
Aarau
University Hospital Basel
RECRUITING
Basel
Inselspital
RECRUITING
Bern
Lindenhof Hospital
RECRUITING
Bern
Cantonal Hospital Biel
RECRUITING
Biel
Cantonal Hospital Chur
RECRUITING
Chur
University Hospital Geneva
RECRUITING
Geneva
Centre hospitalier universitaire vaudois (CHUV)
RECRUITING
Lausanne
Cantonal Hospital Liestal
RECRUITING
Liestal
Cantonal Hospital Luzern
RECRUITING
Lucerne
Ospedale Regionale di Lugano
RECRUITING
Lugano
Cantonal Hospital Neuchâtel
RECRUITING
Neuchâtel
Cantonal Hospital St. Gallen
RECRUITING
Sankt Gallen
Hospital Triemli, Zürich
RECRUITING
Zurich
University Hospital Zürich
RECRUITING
Zurich
Contact Information
Primary
Cyrill Rentsch, Prof. Dr. med.
cyrill.rentsch@usb.ch
+41 61 26 87122
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2040-02
Participants
Target number of participants: 400
Treatments
Experimental: Radical prostatectomy with extended pelvic lymph node dissection
No_intervention: Radical prostatectomy without extended pelvic lymph node dissection
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Basel, Switzerland