Clinical use of [18F]florastamine PET/CT in patients with PI-RADS≤3 report of multi-parametric MRI and suspected prostate cancer
Key facts
- Where
- Klagenfurt Am Woerthersee és Salzburg, AusztriaSee the 2 sites
- Phase
- 3. fázis
Where in Ausztria
- Landeskrankenanstalten-Betriebsgesellschaft KabegKlagenfurt Am Woerthersee, AusztriaNo longer taking part
- Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbHSalzburg, AusztriaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Curium Austria GmbH
- Trial code
- EU 2023-510421-14-00
- Record updated
- 2024. augusztus 12.
- Original description
To analyse the sensitivity of florastamin (18F) PET/CT in localisation of csPCa in patients with elevated serum PSA levels and/or PSA density and with clinical suspicion of PCa and with report of PI-RADS v2.1.Read full original descriptionShow less
Prospective Study of Added Value of Florastamin (18F) PET/CT in Localisation of Clinically Significant Prostate Cancer in Patients with PI- Report of Multi-Parametric MRI, Elevated Serum PSA Levels and/or PSA Density and with Clinical Suspicion of Prostate Cancer
To analyse the sensitivity of florastamin (18F) PET/CT in localisation of csPCa in patients with elevated serum PSA levels and/or PSA density and with clinical suspicion of PCa and with report of PI-RADS v2.1.
Inclusion: Male gender; Age ≥18 years; PSA ≥10ng/mL and/or PSAD≥0.26 ng/mL2; PI-RADS v2 ≤3 report of mpMRI performed less than 3 months prior inclusion; Availability of mpMRI data for centralized reading; Patient scheduled for biopsy or radical prostatectomy; Signed informed consent.
Exclusion: Androgen deprivation therapy or any targeted treatment for PCa prior florastamin (18F) PET/CT; Concomitant active malignancy and/or confirmed metastases; Hypersensitivity to active substance or any of excipients of investigational medicinal product; Past history of confirmed prostate cancer; Absence of any of the inclusion criteria; Life expectancy <6 months; ECOG performance status >2.