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

Conditions

Prostate cancer

Brief summary

Localisation of csPCa in patients with elevated serum PSA levels and/or PSA density and clinical suspicion of PCa. Percentage of true positive (TP) patients among TP divided by (TP + false negative (FN)).

Detailed description

Percentage of true negative (TN) patients among TN divided by (TN + false positive (FP))., Percentage of true positive (TP) sites among TP divided by (TP + false negative (FN))., NRI of florastamin (18F)., Percentage of patients in whom the initially scheduled diagnostic thinking has been modified based on florastamin (18F) PET/CT results., Percentage of patients in whom the therapeutic management of PCa has been modified based on florastamin (18F) PET/CT results., Correlation of patient based diagnostic performance of florastamin (18F) PET/CT with PHI when available., Quantitative uptake of florastamin (18F) by csPCa, Percentage adverse events observed during the first 24 hours florastamin (18F) administration., Correlation of quantitative uptake of florastamin (18F) with histopathological results., Establishment of interpretation criteria.

Related papers

No related papers found yet.

Interventions

DRUGProstavue

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Localisation of csPCa in patients with elevated serum PSA levels and/or PSA density and clinical suspicion of PCa. Percentage of true positive (TP) patients among TP divided by (TP + false negative (FN)).	—

Secondary

Measure	Time frame
Percentage of true negative (TN) patients among TN divided by (TN + false positive (FP))., Percentage of true positive (TP) sites among TP divided by (TP + false negative (FN))., NRI of florastamin (18F)., Percentage of patients in whom the initially scheduled diagnostic thinking has been modified based on florastamin (18F) PET/CT results., Percentage of patients in whom the therapeutic management of PCa has been modified based on florastamin (18F) PET/CT results., Correlation of patient based diagnostic performance of florastamin (18F) PET/CT with PHI when available., Quantitative uptake of florastamin (18F) by csPCa, Percentage adverse events observed during the first 24 hours florastamin (18F) administration., Correlation of quantitative uptake of florastamin (18F) with histopathological results., Establishment of interpretation criteria.	—

Measure

Time frame

Percentage of true negative (TN) patients among TN divided by (TN + false positive (FP))., Percentage of true positive (TP) sites among TP divided by (TP + false negative (FN))., NRI of florastamin (18F)., Percentage of patients in whom the initially scheduled diagnostic thinking has been modified based on florastamin (18F) PET/CT results., Percentage of patients in whom the therapeutic management of PCa has been modified based on florastamin (18F) PET/CT results., Correlation of patient based diagnostic performance of florastamin (18F) PET/CT with PHI when available., Quantitative uptake of florastamin (18F) by csPCa, Percentage adverse events observed during the first 24 hours florastamin (18F) administration., Correlation of quantitative uptake of florastamin (18F) with histopathological results., Establishment of interpretation criteria.

—

Countries

Austria

Outcome results

None listed