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

NCT05000827 | Recruiting DMC

• 2 other identifiers: NL76042.091.212021-8189
• Study Type: interventional
• Target: 706
• Locations: 1 country
• Sites: 1

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%.

Conditions

Prostate Cancer Metastatic; Prostate Cancer; Lymph Node Metastases

Outcome Measures

Primary Outcomes (1)

• Difference in biochemical recurrence rate between groups.

  Biochemical recurrence (BCR) is defined as the occurrence of measurable (\>0.2 ng/ml) prostate specific antigen (PSA), during routinely follow-up up to five years after surgery, determined at two different occasions with at least one week between them.The BCR-rate between the control group and intervention groups will be compared.

  2 years

Secondary Outcomes (12)

• Total number of ePLNDs and PSMA PET/CTs performed and their intervention-related healthcare costs

  up to 5 years post-surgery

• Incidence and types of surgical complications after RARP and ePLND

  up to 1 year post-surgery

• Total nodes resected on ePLND and number of positive and negative nodes within and outside of the standard ePLND template

  up to 5 years post-surgery

• Occurrence of pelvic lymph node metastasis and distant metastasis (visceral, bone, distant lymph nodes, pelvic lymph nodes) on PSMA-PET/CT during follow-up

  up to 5 years post-surgery

• Initiation of salvage therapy

  up to 5 years post-surgery

Study Arms (2)

PSMA PET/CT based indication for ePLND:

EXPERIMENTAL

1. Node-negative PSMA PET/CT \[N0\] and M0: do not perform ePLND 2. Node-positive PSMA PET/CT \[N1\] and M0: perform ePLND

Device: PSMA-PET/CT

Nomogram-based indication for ePLND (standard of care)

ACTIVE COMPARATOR

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

Other: Nomogram

Interventions

PSMA-PET/CT 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).

PSMA PET/CT based indication for ePLND:

Nomogram 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%

Nomogram-based indication for ePLND (standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Canisius-Wilhelmina Hospital: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Canisius Wilhelmina Ziekenhuis

Nijmegen, Gelderland, 6532 SZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Lymphatic Metastasis

Interventions

Nomograms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prognosis; Diagnosis; Models, Statistical; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Models, Theoretical; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jean-Paul A. van Basten

  Canisius-Wilhelmina Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lieke Wever

CONTACT

0681806668; l.wever@antoniusziekenhuis.nl

Study Design

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

Model Details: Intervention 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 Comparator Nomogram-based indication for ePLND (conform current EAU guidelines)

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 11, 2021
• Study Start: July 28, 2021
• Primary Completion: July 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

NL (1)