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

Prostate Cancer Clinical Trial

Official title:

Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05109910
• Other study ID #: M20PRD
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2021
• Est. completion date: November 2027

Study information

• Verified date: October 2021
• Source: The Netherlands Cancer Institute
• Contact: Henk G van der Poel, Prof
• Phone: 0205129111
• Email: h.vd.poel[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 284
• Est. completion date: November 2027
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Pelvic lymph node dissection
Bilateral extended pelvic lymph node dissection

Locations

Country	Name	City	State
Netherlands	NKI-AVL	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistent PSA rate	Persistent PSA is defined as a PSA value = 0.1 ng/ml after radical prostatectomy	6 months after surgery
Secondary	Biochemical recurrence (BCR) rate	BCR is defined as a PSA value = 0.2 ng/ml after radical prostatectomy	3 years after surgery
Secondary	Metastasis-free survival	This is defined as the time between radical prostatectomy to development of metastasis	3 years after surgery
Secondary	Incidence of complications after surgery	According to Clavien-Dindo classification	3 and 6 months after surgery
Secondary	Incidence of salvage therapy after primary surgery	I.e., androgen deprivation therapy, radiation therapy or salvage lymph node dissection	3 years after surgery
Secondary	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	6, 12, 24 and 36 months after surgery
Secondary	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	6, 12, 24 and 36 months after surgery
Secondary	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)	6, 12, 24 and 36 months after surgery
Secondary	Urinary voiding symptoms	Urinary voiding symptoms will be assessed with the International Prostatic Symptoms Score (IPSS), ranging from 0 (best) to 35 (worst)	6, 12, 24 and 36 months after surgery
Secondary	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.	6, 12, 24 and 36 months after surgery