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

The Netherlands Cancer Institute284 enrolled

Overview

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.

The role of an extended pelvic lymph node dissection (ePLND) in patients undergoing radical prostatectomy (RP) remains controversial. An ePLND is the most accurate staging method to assess the presence of lymph node metastases. Lymph node involvement is associated with a significantly worse prognosis and may require immediate or delayed adjuvant therapy. However, an ePLND is associated with an increased risk of complications such as lymphoceles, thromboses and lymphedema, and prolongs surgery and patient recovery. Thus, the diagnostic advantage of PLND should be weighed against the potential morbidity. The therapeutic value of an ePLND remains especially unclear in PCa patients with an estimated risk of lymph node invasion (LNI) ≤ 20%, where only a minority of patients will have nodes harbouring metastases. Prospective trials to address this issue are still lacking.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

284

Conditions

Outcomes

Primary Outcomes

Persistent PSA rate

Persistent PSA is defined as a PSA value ≥ 0.1 ng/ml after radical prostatectomy

Time frame: 6 months after surgery

Secondary Outcomes

Biochemical recurrence (BCR) rate

BCR is defined as a PSA value ≥ 0.2 ng/ml after radical prostatectomy

Time frame: 3 years after surgery

Metastasis-free survival

This is defined as the time between radical prostatectomy to development of metastasis

Time frame: 3 years after surgery

Incidence of complications after surgery

According to Clavien-Dindo classification

Time frame: 3 and 6 months after surgery

Incidence of salvage therapy after primary surgery

I.e., androgen deprivation therapy, radiation therapy or salvage lymph node dissection

Time frame: 3 years after surgery

Global Quality of life after surgery

Quality of life (QoL) will be assessed with the EORTC Core Quality of Life questionnaire's (QLQ-C30) global QoL scale ranging from 0 to 100, higher scores indicate better QoL