Prostate cancer suspected clinically and on the basis of elevated serum Prostate Specific Antigen (PSA) levels and PSA density and with result of multiparametric Magnetic Resonance Imaging (mpMRI) of prostate gland scored =3 according to PI-RADS v2.1 MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10053838 Term:
Conditions
Interventions
Product Name: (18F)-florastamin
Product Code: (18F)-FC303
Pharmaceutical Form: Solution for injection
INN or Proposed INN: (18F)Florastamin
Other descriptive name: (9S,13S)-1-(1-(2-(2-(2-[18F]fluoroe
Sponsors
CURIUM Austria GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • 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; • Absence of any of the exclusion criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11
Exclusion criteria
Exclusion criteria: • Absence of any of the inclusion criteria; • Hypersensitivity to active substance or any of excipients of investigational medicinal product • Life expectancy 2. • Concomitant active malignancy • Past history of confirmed prostate cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To analyse the patient-based sensitivity of florastamin (18F) PET/CT for localisation of csPCa in patients with elevated serum PSA levels and/or PSA density and with clinical suspicion of PCa and with report of mpMRI of prostate gland scored =3 according to PI-RADS v2.1;Secondary Objective: • To assess the patient anf the site-based specificity and positive and negative predictive value and site-based sensitivity of florastamin (18F) PET/CT for localisation of csPCa • To assess the net reclassification index (NRI) of florastamin (18F) for localisation of csPCa • To assess the frequency of impact of florastamin (18F) PET/CT on diagnostic thinking • To assess the frequency of impact of florastamin (18F) PET/CT on patient management. • To correlate the patient based diagnostic performance of florastamin (18F) PET/CT in detection of csPCa with prostate health index (PHI) when available • To correlate quantitative uptake of florastamin (18F) with diagnostic performances in localization of csPCa. • To confirm the safety profile of florastamin (18F) • To correlate quantitative uptake of florastamin (18F) with histopathological results • To refine the interpretation criteria of florastamin (18F) PET/CT;Primary end point(s): Localisation of csPCa by florastamin (18F) PET/CT in patients with elevated serum PSA levels and/or PSA density and with clinical suspicion of PCa. Percentage of true positive (TP) patients among TP divided by (TP + false negative (FN)).;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated on the basis of standard of truth during six month follow-up period in each included subject. For whole study, the primary endpoint will be assessed six months after inclusion of the last evaluable patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 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.;Timepoint(s) of evaluation of this end point: • Impact of florastamin (18F) PET/CT on diagnostic thinking • Impact of florastamin (18F) PET/CT on patient management • Incidental finding(s) of florastamin (18F) PET/CT • Abnormality of biodistribution of florastamin (18F) • Adverse reaction(s) related with use of florastamin (18F) | — |
Countries
Austria
Contacts
Public ContactClinical Trials Information
CURIUM Austria GmbH
Outcome results
None listed