Newly diagnosed prostate cancer, PET/CT scan used to stage newly diagnosed prostate cancer.
Conditions
Interventions
Product Name: Fluor-18-Prostate Specific membrane Antigen (F18-PSMA)
Product Code: 27416229619
Pharmaceutical Form: Solution for infusion
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Men with a newly diagnosed intermediate or high risk (including locally advanced) prostate cancer or low risk with a clinical suspicion of metastases based on other findings, and before any treatment is initiated. • Has given informed consent to participate • Can read and understand provided patient information material in Danish • Biopsy verified, newly diagnosed and untreated PCa • Any, some, or all of the following features: o PSA = 20 ng/ml OR o Gleason Score = 4+3 OR o Tumor stage cT2c or above as determined by digital rectal exploration and/or transrectal ultrasonography OR o Suspicion of metastases as judged clinically • Staging by imaging is warranted 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 298
Exclusion criteria
Exclusion criteria: • Consent not given • Inability to read and/or understand provided patient information in Danish • Previously given consent to this study withdrawn for any reason • Staging by imaging not warranted as judged clinically • Allergy towards NaF, PSMA or other contents in the solutions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Men with a newly diagnosed intermediate or high risk (including locally advanced) prostate cancer or low risk with a clinical suspicion of metastases based on other findings, and before any treatment is initiated.;Secondary Objective: Not applicable;Primary end point(s): Primary endpoints (Group A vs. B) 1. Treatment strategies and progression-free survival 2. Quality of life measures;Timepoint(s) of evaluation of this end point: At the end of the recruition period (3 years after start of inclusion). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints Accuracy measures comprise analyses of Receiver Operating Curve and Area Under the Curve, sensitivity, specificity, positive and negative predictive values, and likelihood ratio. Biopsy of suspected metastatic lesions will be intended and used as a reference standard as well as a nadir unmeasurably low prostate-specific antigen blood sample. Accuracy analyses will be performed for: • PSMA-PET/CT vs. NaF-PET/CT for evaluation of bone metastases • PSMA-PET/MR vs. pathology in tumor staging • Overall survival (group A vs. group B);Timepoint(s) of evaluation of this end point: After recruition period, and in the following years for overall survival. | — |
Countries
Denmark
Contacts
Public ContactDepartment of Nuclear Medicine
Odense University Hospital
Outcome results
None listed