Clinical trial NCT05109910: The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy
Official title: Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lymph node dissection
Prostatectomy
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 284
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Persistent PSA rate
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Biochemical recurrence (BCR) rate
timeFrame: 3 years after surgery
measure: Metastasis-free survival
timeFrame: 3 years after surgery
measure: Incidence of complications after surgery
timeFrame: 3 and 6 months after surgery
measure: Incidence of salvage therapy after primary surgery
timeFrame: 3 years after surgery
measure: Global Quality of life after surgery
timeFrame: 6, 12, 24 and 36 months after surgery
measure: Health-related quality of life of patients with prostate cancer
timeFrame: 6, 12, 24 and 36 months after surgery
measure: Urinary continence after surgery
timeFrame: 6, 12, 24 and 36 months after surgery
measure: Urinary voiding symptoms
timeFrame: 6, 12, 24 and 36 months after surgery
measure: Potency after surgery
timeFrame: 6, 12, 24 and 36 months after surgery
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: NKI-AVL
Study officials:
affiliation: The Netherlands Cancer Institute
name: Henk G van der Poel, Prof
role: PRINCIPAL_INVESTIGATOR
References: