Multi-institutional Evaluation of the Cost-effectiveness of PSMA-PET/CTfor the Detection of Pelvic Lymph Node Invasion in Newly Diagnosed Prostate CancerPatients

Phase 1

Conditions: Patients with newly-diagnosed PCa, without evidence of distant metastasis (any T, M0), whoare candidates for treatment with radical prostatectomy and ePLND based on a nomogramcalculatedrisk of LNI >5% are selected for the study.
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2021-002055-12-NL

Lead Sponsor: Canisius Wilhelmina Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 706

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following
criteria:
1. Biopsy proven adenocarcinoma of the prostate
2. Indication for ePLND combined with RARP
3. Suitable for robot-assisted ePLND + RARP
4. Mentally competent and understanding of benefits and potential burden of the study
5. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 353
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 353

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine if the use of PSMA PET/CT as a selection tool for performing ePLND for PCa<br>in the primary staging setting results in comparable oncological outcomes in terms of<br>biochemical recurrence compared to the current European Guideline-recommended<br>standard practice which includes performing ePLND in PCa patients who are candidates<br>for active treatment with a nomogram-calculated LNI risk >5%.;Secondary Objective: If use of PSMA PET/CT as a selection tool for ePLND in the primary PCa staging setting<br>results in fewer ePLND procedures and therefore lower overall healthcare costs and less<br>patient burden in terms of intervention-related complications and morbidity compared to<br>the current standard practice.;Primary end point(s): - Biochemical recurrence rate within two years after surgery, defined as a PSA > 0.2<br>ng/ml.;Timepoint(s) of evaluation of this end point: - Two years to assess biochemical recurrence rates.<br>

Secondary Outcome Measures