Actively Recruiting
The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy
Led by The Netherlands Cancer Institute · Updated on 2021-11-18
284
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An extended pelvic lymph node dissection (ePLND) is the most accurate staging method to assess the presence of lymph node metastases in prostate cancer (PCa) patients. The therapeutic value, however remains unclear. Prospective randomized trials to address this void are lacking. Since in intermediate and a proportion of high risk PCa the risk of nodal metastases is generally below 25%, the vast majority of men undergo a procedure that has no oncological benefit, but is not without toxicity. Therefore, the investigators aim to compare the oncologic outcomes of intermediate- and high-risk PCa patients with an estimated risk of lymph node invasion of 5-20% undergoing a radical prostatectomy (RP) with or without an ePLND.
CONDITIONS
Official Title
The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, aged 18 years or older
- Prostate cancer patients with a Briganti calculated risk of lymph node metastases of 5-20% without evidence of metastases on PSMA PET/CT
- Scheduled for a (robot-assisted) laparoscopic radical prostatectomy
- Written informed consent provided
You will not qualify if you...
- American Society of Anaesthesiology (ASA) classification greater than 3
- Contraindication for lymphadenectomy
- Receiving neoadjuvant hormone deprivation therapy
- Absence or withdrawal of informed consent
- Evidence of metastases on pre-operative PSMA PET/CT
AI-Screening
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Trial Site Locations
Total: 1 location
1
NKI-AVL
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
Research Team
H
Henk G van der Poel, Prof
CONTACT
H
Hilda A de Barros, MD
CONTACT
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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