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

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 (PSMA-Select)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24993

Enrollment

546

Registered

2020-12-13

Start date

2020-12-13

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Interventions

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

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Biochemical recurrence rate within two years after surgery, defined as a PSA > 0.2 ng/ml.	—

Secondary

Measure	Time frame
- 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 - Total nodes resected during ePLND and number of positive and negative nodes. - Modification of ePLND template; resected nodes within and outside of the normal ePLND template - Occurrence of pelvic lymph node metastasis and distant metastasis (visceral, bone, distant lymph nodes, pelvic lymph nodes) on PSMA-PET/CT during follow-up - Initiation of salvage therapy - Metastasis-free survival - Hormone-therapy free survival - Patient-reported outcome measures (EPIC-26) - Quality of life (EQ-5D questionnaire) - Medical consumption costs using the Medical Consumption Questionnaire (MCQ) - Productivity losses using the productivity Cost Questionnaire (PCQ) - Diagnostic accuracy measures	—

Measure

Time frame

- 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 - Total nodes resected during ePLND and number of positive and negative nodes. - Modification of ePLND template; resected nodes within and outside of the normal ePLND template - Occurrence of pelvic lymph node metastasis and distant metastasis (visceral, bone, distant lymph nodes, pelvic lymph nodes) on PSMA-PET/CT during follow-up - Initiation of salvage therapy - Metastasis-free survival - Hormone-therapy free survival - Patient-reported outcome measures (EPIC-26) - Quality of life (EQ-5D questionnaire) - Medical consumption costs using the Medical Consumption Questionnaire (MCQ) - Productivity losses using the productivity Cost Questionnaire (PCQ) - Diagnostic accuracy measures

—

Contacts

Public ContactLieke Wever

St. Antonius Ziekenhuis

l.wever@antoniusziekenhuis.nl0652742318

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)