Dutch National Randomized Study: PSMA-PET/CT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients

NCT ID: NCT05000827

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 706 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2026-08-31

Brief Summary

To determine if the use of Prostate-Specific Membrane Antigen Positron Emission Computer Tomography (PSMA PET/CT) as a selection tool for performing extended lymph node dissection (ePLND) for prostate cancer (PCa) in the primary staging setting results in fewer ePLND procedures and therefore lower overall healthcare costs, lower patient burden in terms of intervention-related complications and morbidity, with comparable disease prognosis, compared to the current European Guideline-recommended standard practice which includes performing ePLND in PCa patients who are candidates for active treatment with a nomogram-calculated lymph node involvement (LNI) risk >5%.

Detailed Description

Background: Use of prostate-specific membrane antigen (PSMA) positron emission tomography (PET) - computer tomography (CT) has drastically improved the ability to detect and exclude presence of pelvic lymph node invasion (LNI) compared to conventional imaging. However, current standard of care still includes performing extended pelvic lymph node dissection (ePLND) in all patients with primary prostate cancer and a nomogram-based risk of LNI >5%. It is unclear if use of PSMA PET/CT as a triage test can safely reduce the number of ePLND and hence reduce the associated morbidity and costs, without negatively influencing disease prognosis.

Objective: To assess whether PSMA PET/CT can be safely used as a triage test for selecting primary prostate cancer patients for ePLND. We will additionally assess cost-effectiveness of the PSMA PET/ CT triage strategy.

Design, setting and Participants: THE PSMA-SELECT trial includes patients with biopsy-confirmed prostate cancer, without evidence of distant metastasis (M0) on PSMA PET/CT, opting for treatment with radical prostatectomy (RP), with a nomogram-calculated risk of LNI >5%. Patients will be randomized 1:1. In the intervention arm patients will only undergo ePLND in addition to robot-assisted radical prostatectomy (RARP) in case of suspected LNI on PSMA PET/CT (miN1), whereas ePLND will be omitted in those without PSMA positive lymph nodes (miN0). In the control arm, all patients will undergo ePLND in addition to RARP.

Outcome measurements and statistical analysis: The primary endpoint of this study is biochemical recurrence rate at two years post-surgery. Secondary outcome measures are number of ePLNDs indicated and performed, treatment-related adverse events, initiation of salvage treatment, metastasis-free survival, patient-reported outcome measures and individual and cumulative healthcare costs.

Conditions

Prostate Cancer Metastatic; Prostate Cancer; Lymph Node Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PSMA PET/CT based indication for ePLND:

1. Node-negative PSMA PET/CT [N0] and M0: do not perform ePLND

2. Node-positive PSMA PET/CT [N1] and M0: perform ePLND

Group Type: EXPERIMENTAL

PSMA-PET/CT

Intervention Type: DEVICE

In the intervention arm patients will only undergo ePLND in addition to robot-assisted radical prostatectomy (RARP) in case of suspected LNI on PSMA PET/CT (miN1), whereas ePLND will be omitted in those without PSMA positive lymph nodes (miN0).

Nomogram-based indication for ePLND (standard of care)

Nomogram-based indication for ePLND (conform current EAU guidelines)

Group Type: ACTIVE_COMPARATOR

Nomogram

Intervention Type: OTHER

Current standard of care includes performing extended pelvic lymph node dissection (ePLND) in all patients with primary prostate cancer and a nomogram-based risk of LNI \>5%

Interventions

PSMA-PET/CT

In the intervention arm patients will only undergo ePLND in addition to robot-assisted radical prostatectomy (RARP) in case of suspected LNI on PSMA PET/CT (miN1), whereas ePLND will be omitted in those without PSMA positive lymph nodes (miN0).

Intervention Type: DEVICE

Nomogram

Current standard of care includes performing extended pelvic lymph node dissection (ePLND) in all patients with primary prostate cancer and a nomogram-based risk of LNI \>5%

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Biopsy proven adenocarcinoma of the prostate
• Indication for ePLND combined with robot assisted radical prostatectomy (RARP) (MSKCC nomogram >5%, if not applicable when only MRI targeted biopsies are positive, the Briganti nomogram will be used)
• Suitable for robot-assisted ePLND and RARP
• Mentally competent and understanding of benefits and potential burden of the study
• Written informed consent
• No known allergies for PSMA tracer.

Exclusion Criteria

• History of prior diagnosed or treated PCa
• Known concomitant malignancies (except Basal Cell Carcinoma of the skin)
• Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RARP
• PSMA non-avid PCa (local tumor activity)
• Presence of distant metastasis (M1)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Canisius-Wilhelmina Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Paul A. van Basten

Role: PRINCIPAL_INVESTIGATOR

Canisius-Wilhelmina Hospital

Locations

Canisius Wilhelmina Ziekenhuis

Nijmegen, Gelderland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Lieke Wever

Role: CONTACT

l.wever@antoniusziekenhuis.nl

0681806668

Facility Contacts

L Wever

Role: primary

l.wever@cwz.nl

0681806668 ext. +316

Other Identifiers

2021-8189

Identifier Type: REGISTRY

Identifier Source: secondary_id

NL76042.091.21

Identifier Type: -

Identifier Source: org_study_id