Actively Recruiting
Extended Pelvic Lymph Node Dissection vs. No Pelvic Lymph Node Dissection During Radical Prostatectomy in PSMA PET Negative High-Risk Prostate Cancer Men
Led by University Hospital, Basel, Switzerland · Updated on 2025-07-03
400
Participants Needed
15
Research Sites
678 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to determine whether performing an extended pelvic lymph node dissection (ePLND) during radical prostatectomy benefits men with high-risk prostate cancer. The study investigates if ePLND improves cancer staging and removes undetectable cancer cells that standard imaging techniques like PSMA-PET might miss, potentially leading to better treatment outcomes. The trial is a multicenter, randomized phase III study sponsored by University Hospital, Basel, Switzerland. Participants will be randomly assigned to one of two groups: radical prostatectomy with extended pelvic lymph node dissection or radical prostatectomy without the extended lymph node dissection. Extended PLND involves removing more lymph nodes than the standard procedure, aiming for better detection of cancer spread. The study compares outcomes between these two approaches, while considering surgery time and complication risks, which may be slightly higher with ePLND. During the study, participants will be monitored over a long-term period of up to 10 to 15 years. Researchers will measure prostate-specific antigen (PSA) persistence about 3 months after surgery and track biochemical recurrence-free survival within 24 months. Secondary measures include time to recurrence, metastasis, survival rates, complications, adverse events related to ePLND, and patient-reported outcomes. This comprehensive follow-up includes assessments during surgery, postoperatively, and over many years to evaluate the overall impact of the surgical approaches.
CONDITIONS
Brief Title
Extended vs. No Pelvic Lymph Node Dissection During Radical Prostatectomy. DISSECTION 2.0.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with life expectancy over 15 years
- Biopsy-proven prostate cancer of WHO/ISUP grade groups III to V
- High-risk prostate cancer defined by biopsy grade group III to V or grade group II with PSA over 20 ng/ml
- Negative PSMA-PET scan showing no regional or distant metastasis
- Recommendation from a multidisciplinary tumor board for radical prostatectomy
- WHO performance status 0 to 1
- Suitable condition for general anesthesia and radical prostatectomy (ASA score 3 or less)
You will not qualify if you...
- Prostate cancer grade group I with clinical stage T1 or T2
- Clinical stage T4 prostate cancer
- Positive PSMA-PET scan for local or distant metastasis
- Previous neoadjuvant, local, or systemic treatment for prostate cancer
- Prior pelvic lymph node dissection or pelvic radiotherapy
- Recent prior malignancy treated with curative intent less than 2 years ago, except low-risk malignancies
- Serious medical, psychiatric, psychological, familial, or geographical conditions that interfere with treatment or follow-up
- Vulnerable men unable to provide informed consent or under legal guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and hospital stay duration
Participants undergo radical prostatectomy with or without extended pelvic lymph node dissection. They are monitored for intraoperative and immediate postoperative complications.
1 surgical procedure and hospital stay
Duration - Up to 10 to 15 years
Participants are followed to monitor prostate specific antigen (PSA) levels, biochemical recurrence, complications, adverse events, and patient-reported outcomes for up to 10 to 15 years after surgery.
Regular follow-up visits including a 3 month postoperative visit and visits within 24 months and long-term follow-up
Trial Site Locations
Total: 15 locations
1
Cantonal Hospital Aarau
Aarau, Switzerland
Actively Recruiting
2
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
3
Inselspital
Bern, Switzerland
Actively Recruiting
4
Lindenhof Hospital
Bern, Switzerland
Actively Recruiting
5
Cantonal Hospital Biel
Biel, Switzerland
Actively Recruiting
6
Cantonal Hospital Chur
Chur, Switzerland
Actively Recruiting
7
University Hospital Geneva
Geneva, Switzerland
Actively Recruiting
8
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, Switzerland
Actively Recruiting
9
Cantonal Hospital Liestal
Liestal, Switzerland, 4410
Actively Recruiting
10
Cantonal Hospital Luzern
Lucerne, Switzerland
Actively Recruiting
11
Ospedale Regionale di Lugano
Lugano, Switzerland
Actively Recruiting
12
Cantonal Hospital Neuchâtel
Neuchâtel, Switzerland
Actively Recruiting
13
Cantonal Hospital St. Gallen
Sankt Gallen, Switzerland
Actively Recruiting
14
Hospital Triemli, Zürich
Zurich, Switzerland
Actively Recruiting
15
University Hospital Zürich
Zurich, Switzerland
Actively Recruiting
Research Team
C
Cyrill Rentsch, Prof. Dr. med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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