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Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy

NCT04269512 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3650

Last updated 2026-01-12

No results posted yet for this study

Summary

Currently, lymph node dissection is standard of care during prostatectomy of intermediate risk tumors at the Martini Clinic. It allows the assessment of possible but unlikely lymph nodes metastases. In case of lymph node metastasis, depending on the number of affected lymph nodes, an adjuvant radiation with or without additional hormone therapy may be discussed in order to stop or delay further progression of the disease.

Since the procedure carries additional risks, it is controversial. The risks include prolonged surgery duration, injury of vessels and nerves, as well as disorders of lymphatic circulation after surgery. Moreover, formation of lymphoceles (accumulation of lymph fluid in the tissue) are common, which may result in soft tissue swelling, thrombosis, inflammation and additional surgical procedures.

Therefore, the aim of this study is to evaluate whether the removal of the lymph nodes during prostatectomy positively influences the course of the disease in patients with intermediate risk prostate cancer, or if the lymph node dissection does not have any influence on the recurrence of the disease and therefore further therapies.

In this case, the omission of lymph node dissection may avoid an unnecessary expansion of the operation and the potentially associated side effects linked to it. This is particularly of interest considering the rapidly advancing technical possibilities, both in imaging and in the treatment of prostate cancer, since this enables an earlier and more individual intervention in the case of recurrence.

Conditions

Interventions

PROCEDURE

lymph node dissection

At least 10 lymph nodes must be removed.

Sponsors & Collaborators

  • Martini-Klinik am UKE GmbH

    lead OTHER

Principal Investigators

  • Markus Graefen · Director

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
2019-10-15
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • Germany

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 NCT04269512 on ClinicalTrials.gov