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

Recruiting

• Conditions: lymphnode invasion for prostate cancer; 10027476; 10036958; 10025506

• Registration Number: NL-OMON56406
• Lead Sponsor: Canisius Wilhelmina Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 742

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Age >=18 years
2. Biopsy proven adenocarcinoma of the prostate
3. Indication for extended pelvic lymph node dissection (ePLND) combined with
robot assisted radical prostatectomy (RARP)
4. Suitable for robot-assisted ePLND + RARP
5. Mentally competent and understanding of benefits and potential burden of the
study
6. Written informed consent

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from
participation in this study:
1. History of prior diagnosed or treated PCa
2. Known concomitant malignancies (except Basal Cell Carcinoma of the skin)
3.Unwillingness or inability to undergo PSMA PET/CT and/or ePLND
4. PSMA non-avid PCa (local tumor activity)
5. Presence of distant metastasis (M1)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the biochemical recurrence rate within two years<br /><br>after surgery, defined as a PSA > 0.2 ng/ml. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine if of PSMA PET/CT as a staging tool may also serve as a selection<br /><br>tool for ePLND in those men who are indicated for radical prostatectomy results<br /><br>in fewer ePLND procedures and therefore lower overall healthcare costs and less<br /><br>patient burden in terms of intervention-related complications and morbidity<br /><br>compared to the current standard practice of nomogram based ePLND in radical<br /><br>prostatectomy. . </p><br>