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

Conditions: Prostate Cancer

Registration Number: NL-OMON24993

Lead Sponsor: Canisius Wilhelmina Hospital (CWZ)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 546

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1.>18 years
2. Biopsy proven adenocarcinoma of the prostate
3. 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)
4. Suitable for robot-assisted ePLND and RARP
5. Mentally competent and understanding of benefits and potential burden of the study 5. Written informed consent
6. No known allergies for PSMA tracer.

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 and RARP
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
Biochemical recurrence rate within two years after surgery, defined as a PSA > 0.2 ng/ml.

Secondary Outcome Measures

Name	Time	Method
- Total number of ePLNDs and PSMA PET/CTs performed and their intervention-related healthcare costs, costs of complication-related interventions and associated (prolonged) hospital stay<br>- Total nodes resected during ePLND and number of positive and negative nodes.<br>- Modification of ePLND template; resected nodes within and outside of the normal ePLND template<br>- Occurrence of pelvic lymph node metastasis and distant metastasis (visceral, bone, distant lymph nodes, pelvic lymph nodes) on PSMA-PET/CT during follow-up<br>- Initiation of salvage therapy<br>- Metastasis-free survival<br>- Hormone-therapy free survival<br>- Patient-reported outcome measures (EPIC-26)<br>- Quality of life (EQ-5D questionnaire)<br>- Medical consumption costs using the Medical Consumption Questionnaire (MCQ)<br>- Productivity losses using the productivity Cost Questionnaire (PCQ)<br>- Diagnostic accuracy measures