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

NCT ID: NCT05109910

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-17

Study Completion Date

2027-11-30

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Keywords

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Prostate Cancer Lymph node dissection Prostatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radical prostatectomy with an extended pelvic lymph node dissection

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.

Group Type ACTIVE_COMPARATOR

Pelvic lymph node dissection

Intervention Type PROCEDURE

Bilateral extended pelvic lymph node dissection

Radical prostatectomy without an extended 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pelvic lymph node dissection

Bilateral extended pelvic lymph node dissection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The Netherlands Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henk G van der Poel, Prof

Role: PRINCIPAL_INVESTIGATOR

The Netherlands Cancer Institute

Locations

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NKI-AVL

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Henk G van der Poel, Prof

Role: CONTACT

Phone: 0205129111

Email: [email protected]

Hilda A de Barros, MD

Role: CONTACT

Phone: 0205129111

Email: [email protected]

Facility Contacts

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H.G van der Poel, Prof

Role: primary

Other Identifiers

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M20PRD

Identifier Type: -

Identifier Source: org_study_id