Metastatic Castration Resistant Prostate Cancer (mCRPC) MedDRA version: 19.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Zytiga
Pharmaceutical Form: Tablet
Sponsors
Radboud UMC
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - patients with metastatic castration resistant prostate cancer* who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated – OR – who have been treated upfront with 6 cycles of docetaxel: conform the Chaarted or Stampede trials- Age =18 years - Feasible to collect blood samples from - Life expectancy of > 6 months - Measurable disease - Able and willing to give written informed consent prior to screening and enrollment *definition of CRPC according to EAU guidelines 2014 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: The study objective is to explore the effect of abiraterone exposure on treatment and biomarker response in group of patients treated with abiraterone acetate in agreement with the drug label. Therefore the exclusion criteria as listed in the package insert will be used in this study. Additionally, patients are not allowed to be treated with other anticancer therapies, potent CYP3A4 inhibitors or inducers and herbal medicine that could interfere with abiraterone exposure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate a relation of abiraterone exposure (area under the curve) with treatment response (following RECIST criteria for complete remission, partial remission and stable disease, primarily based on radiographic response and secondary on biochemistry (=25% decrease in PSA).;Secondary Objective: -To explore the relation between novel early and easily assessable biomarkers (PSA-mRNA, PCA3-mRNA, TMPRSS2:ERP gene fusion-mRNA, (currently under development)ARv7 mRNA and ARwt mRNA) and treatment response after 3 months and 6 months of therapy -To explore whether the degree of reductions of these novel biomarkers are related to abiraterone exposure (AUC) after 3 and 6 months of therapy -To explore the relation between traditional PD biomarkers (serum PSA, DHEA, LDH, AP) and treatment response after 3 and 6 months of therapy -To explore whether the degree of reductions in PSA, DHEA, LDH, AP are related to abiraterone exposure (AUC) after 3 and 6 months of therapy ;Primary end point(s): To demonstrate a relation of abiraterone exposure (area under the curve) with treatment response ;Timepoint(s) of evaluation of this end point: Respons Assessment: Day 84(±4d) ; Day 168(±4d) Pharmacokinetics: Day 28(±2d) ; Day 84(±4d) ; Day 168(±4d) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -To explore the relation between novel early and easily assessable biomarkers (PSA-mRNA, PCA3-mRNA, TMPRSS2:ERP gene fusion-mRNA, (currently under development)ARv7 mRNA and ARwt mRNA) and treatment response after 3 months and 6 months of therapy -To explore whether the degree of reductions of these novel biomarkers are related to abiraterone exposure (AUC) after 3 and 6 months of therapy -To explore the relation between traditional PD biomarkers (serum PSA, DHEA, LDH, AP) and treatment response after 3 and 6 months of therapy -To explore whether the degree of reductions in PSA, DHEA, LDH, AP are related to abiraterone exposure (AUC) after 3 and 6 months of therapy ;Timepoint(s) of evaluation of this end point: Pharmacodynamics(biomarkers assessment): Day 28(±2d) ; Day 84(±4d) ; Day 168(±4d) Pharmacokinetics: Day 28(±2d) ; Day 84(±4d) ; Day 168(±4d) Treatment response: Day 84(±4d) ; Day 168(±4d) | — |
Countries
Netherlands
Contacts
Public ContactApotheek
RadboudUMC
Outcome results
None listed