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The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy

RECRUITINGN/ASponsored by The Netherlands Cancer Institute
Actively Recruiting
PhaseN/A
SponsorThe Netherlands Cancer Institute
Started2021-11-17
Est. completion2024-11
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
Inclusion Criteria:

* Male, aged ≥ 18 years
* Prostate cancer patients with a Briganti calculated risk of LN metastases of 5-20% without evidence of metastases on Prostate-Specific Membrane Antigen (PSMA) PET/CT requiring an ePLND in the standard treatment
* Scheduled for a (robot-assisted) laparoscopic radical prostatectomy
* Written informed consent

Exclusion Criteria:

* American Society of Anaesthesiology (ASA) classification \> 3
* Patients with a contradiction for a lymphadenectomy
* Neoadjuvant hormone deprivation therapy
* Absence or withdrawal of an informed consent
* Evidence of metastases on pre-operative PSMA PET/CT

Conditions2

CancerProstate Cancer

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