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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2026
  • participants needed
    706
  • sponsor
    Canisius-Wilhelmina Hospital
Updated on 25 August 2021

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%.

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.

Details
Condition Prostatic disorder, Prostate Cancer, Prostate Cancer, Early, Recurrent, Prostate Disorders, Metastatic Prostate Cancer, prostate carcinoma, prostate cancers, Malignant neoplasm of prostate, Lymph Node Metastases, Prostate Cancer Metastatic, Lymph Node Metastasis
Treatment PSMA-PET/CT, Nomogram, Nomogram
Clinical Study IdentifierNCT05000827
SponsorCanisius-Wilhelmina Hospital
Last Modified on25 August 2021

Eligibility

Yes No Not Sure

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)
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