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

NCT05109910 | Recruiting

• 1 other identifier: M20PRD
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Lymph node dissection; Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Persistent PSA rate

  Persistent PSA is defined as a PSA value ≥ 0.1 ng/ml after radical prostatectomy

  6 months after surgery

Secondary Outcomes (9)

• Biochemical recurrence (BCR) rate

  3 years after surgery

• Metastasis-free survival

  3 years after surgery

• Incidence of complications after surgery

  3 and 6 months after surgery

• Incidence of salvage therapy after primary surgery

  3 years after surgery

• Global Quality of life after surgery

  6, 12, 24 and 36 months after surgery

Study Arms (2)

Radical prostatectomy with an extended pelvic lymph node dissection

ACTIVE COMPARATOR

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

Radical prostatectomy without an extended pelvic lymph node dissection

NO INTERVENTION

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.

Interventions

Pelvic lymph node dissection PROCEDURE

Bilateral extended pelvic lymph node dissection

Radical prostatectomy with an extended pelvic lymph node dissection

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Presence of prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

NKI-AVL

Amsterdam, 1066 CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Henk G van der Poel, Prof

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henk G van der Poel, Prof

CONTACT

0205129111; h.vd.poel@nki.nl

Hilda A de Barros, MD

CONTACT

0205129111; h.d.barros@nki.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: November 5, 2021
• Study Start: November 17, 2021
• Primary Completion: November 1, 2024
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)