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

Netherlands Cancer Institute (NKI)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Procedure: Pelvic lymph node dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT05109910

M20PRD

Details and patient eligibility

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.

Full description

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.

Enrollment: 284 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 2 patient groups

Radical prostatectomy with an extended pelvic lymph node dissection

Active Comparator group

Description:

According to the standard of care, patients in this arm will receive a radical prostatectomy with a standard bilateral ePLND. This includes the removal of lymph nodes within the obturator fossa and bilateral to the external iliac artery, internal iliac artery and common iliac artery up to the ureteral-vessel crossing.

Treatment:

Procedure: Pelvic lymph node dissection

Radical prostatectomy without an extended pelvic lymph node dissection

No Intervention group

Description:

Patients in this arm will undergo a radical prostatectomy without a bilateral extended pelvic lymph node dissection. In case of intraoperatively found suspicious lymph nodes, a lymphadenectomy is performed. According to the intention to treat principle, patients with intraoperatively removed lymph nodes remain included in the study.