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Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer

NCT03921996 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2023-03-09

No results posted yet for this study

Summary

For patients with intermediate-risk prostate cancer plus a predicted risk of \>5% for positive lymph nodes and with high-risk prostate cancer, international guidelines recommend ePLND along with the RP. Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. We hypothesize that ePLND prolongs time to biochemical recurrence (BCR) and prostate cancer-specific survival (PCSS) in intermediate- and high-risk PCa patients.

Conditions

Interventions

PROCEDURE

Radical prostatectomy (RP) followed by ePLND

ePLND is performed either before or after radical prostatectomy and includes the removal of all nodal and fibro-fatty tissue

PROCEDURE

Radical prostatectomy (RP) only

Radical prostatectomy

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Cyrill A. Rentsch, MD-PhD · University Hospital Basel, Department of Urology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-27
Primary Completion
2021-11-11
Completion
2021-11-11

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03921996 on ClinicalTrials.gov