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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
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518171-59-00
Acronym
NL76042.091.21
Enrollment
742
Registered
2025-01-23
Start date
2025-01-23
Completion date
Unknown
Last updated
2025-07-31

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

Conditions

Prostate Cancer

Brief summary

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

Detailed description

- 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. - Biochemical persistence, defined as PSA >0.1 within half a year after surgery - Surgical complications within 6 months after surgery. - Total nodes resected on ePLND and number of positive and negative nodes within and outside of the standard ePLND template. The necessity for a second PSMA PET / CT.

Interventions

Sponsors

Canisius Wilhelmina Ziekenhuis
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime 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. - Biochemical persistence, defined as PSA >0.1 within half a year after surgery - Surgical complications within 6 months after surgery. - Total nodes resected on ePLND and number of positive and negative nodes within and outside of the standard ePLND template. The necessity for a second PSMA PET / CT.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026