An interventional study of Pelvic lymph node dissection in Prostate Cancer, sponsored by The Netherlands Cancer Institute. Recruiting at 1 site in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-18.
Sponsored by The Netherlands Cancer Institute · Not applicable, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 284 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →The Netherlands Cancer Institute is the lead sponsor of 224 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
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.
Procedure: Pelvic lymph node dissection
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.
Bilateral extended pelvic lymph node dissection
Persistent PSA rate
Persistent PSA is defined as a PSA value ≥ 0.1 ng/ml after radical prostatectomy
Time frame: 6 months after surgery
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
Time frame: 6, 12, 24 and 36 months after surgery
Health-related quality of life of patients with prostate cancer
Health-related quality of life in prostate cancer patients will be assessed with the EORTC Quality of Life Questionnaire - Prostate Cancer Module (QLQ-PR25) with a scale ranging from 0 to 100, higher scores indicate either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of (sexual) activity or functioning
Time frame: 6, 12, 24 and 36 months after surgery
Urinary continence after surgery
Urinary continence will be assessed with the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) questionnaire, ranging from 0 (best) to 21 (worst)
Time frame: 6, 12, 24 and 36 months after surgery
Urinary voiding symptoms
Urinary voiding symptoms will be assessed with the International Prostatic Symptoms Score (IPSS), ranging from 0 (best) to 35 (worst)
Time frame: 6, 12, 24 and 36 months after surgery
Potency after surgery
Potency will be assessed with the International Index of Erectile Function (IIEF) questionnaire. The IIEF classifies the severity of erectile dysfunction into five categories stratified by score: No erectile dysfunction. Score: 26-30 Mild erectile dysfunction. Score: 22-25 Mild to moderate erectile dysfunction. Score: 17-21 Moderate erectile dysfunction. Score: 11-16 Severe erectile dysfunction. Score: 6-10.
Time frame: 6, 12, 24 and 36 months after surgery
Plan to share: No
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