Multi-institutional Evaluation of the Cost-effectiveness of PSMA-PET/CT for the Detection of Pelvic Lymph Node Invasion in Newly Diagnosed Prostate Cancer Patients

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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%.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Canisius Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Contact Information
Primary
Lieke Wever
l.wever@antoniusziekenhuis.nl
0681806668
Time Frame
Start Date: 2021-07-28
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 706
Treatments
Experimental: 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
Active_comparator: Nomogram-based indication for ePLND (standard of care)
Nomogram-based indication for ePLND (conform current EAU guidelines)
Related Therapeutic Areas
Sponsors
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Leads: Canisius-Wilhelmina Hospital

This content was sourced from clinicaltrials.gov

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