Prostate Cancer
Conditions
Interventions
For the purpose of this study a catheter directed angiography of the prostate
arteries will be performed and either CPAE with 50 um resorbable particle or
direct arterial administration of radiotrac
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age >18 years * Confirmed histological diagnosis of PCa; * The Eastern Cooperative Oncology Group (ECOG) performance status * 2 * Received a baseline multi-parametric MRI and PSMA PET/CT * 6 month prior to intra-arterial treatment * Demonstrate adequate hematologic and organ function, defined by the following laboratory results. * All screening laboratory tests should be performed within 30 days prior to the procedure: Absolute neutrophil count (ANC) * 1500 cells/*L Platelet count * 100.000/*L Hemoglobin * 5.6 mmol/L AST and ALT * 3 Serum bilirubin * 1.5 Serum Creatinine * 1.5 x ULN OR measured of calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) * 40 mL/min for subject with creatinine levels * Signed Informed Consent Form
Exclusion criteria
Exclusion criteria: * A potential subject who meets any of the following criteria will be excluded from participation in this study: * Concomitant malignancies, please describe * Severe allergy for iodine based contrast agents * Prior treatments with brachytherapy or prostatectomy. . Inability to undergo intra-aterial procedure secondary to vascular abnormalities . Body weight over 150kg . Severe allergy for I.V. contrast used in angiography
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Increase of the amount of tracer in the prostate gland by 20% compared to systemic administration evaluated via the radiation within the blood draws or measured on PET/CT images compared to systemic PET * Improved PET/CT imaging quality and accuracy of detecting the primary prostate tumor within the prostate gland or local lymph node identification after local administration compared to standard of care systemic | — |
Secondary
| Measure | Time frame |
|---|---|
| * Multi-parametric MRI of the prostate to evaluate the changes to the vascularity after the procedure with comparison to baseline pre-PET tracer administration MRI imaging findings to verify normal profusion after the arterial administration. | — |
Countries
Netherlands
Outcome results
None listed