The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pelvic lymph node dissection.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy
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.
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.
Interventions
- Procedure Pelvic lymph node dissection
Bilateral extended pelvic lymph node dissection
Primary outcome measures
- Persistent PSA rate [Time frame: 6 months after surgery]
Secondary outcome measures (9)
- Biochemical recurrence (BCR) rate [Time frame: 3 years after surgery]
- Metastasis-free survival [Time frame: 3 years after surgery]
- Incidence of complications after surgery [Time frame: 3 and 6 months after surgery]
- Incidence of salvage therapy after primary surgery [Time frame: 3 years after surgery]
- Global Quality of life after surgery [Time frame: 6, 12, 24 and 36 months after surgery]
- Health-related quality of life of patients with prostate cancer [Time frame: 6, 12, 24 and 36 months after surgery]
- Urinary continence after surgery [Time frame: 6, 12, 24 and 36 months after surgery]
- Urinary voiding symptoms [Time frame: 6, 12, 24 and 36 months after surgery]
- Potency after surgery [Time frame: 6, 12, 24 and 36 months after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- NKI-AVL — Amsterdam
Identifiers
NCT: NCT05109910 · M20PRD