Metastatic Castration Resistant Prostate Cancer (mCRPC) MedDRA version: 19.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 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) MedDRA version: 19.1 Level: PT Classification code 10062904 Term: Ho
Conditions
Sponsors
Radboud University Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion criteria: - Male patients with metastatic castration resistant prostate cancer* who are chemotherapy naive OR have been treated upfront with 6 cycles of docetaxel: conform the Chaarted or Stampede trials - Age at least 18 years - Patients from who it is possible to collect blood samples - Patient who are able and willing to give written informed consent prior to screening and enrollment - Life expectancy of > 6 months - Measurable disease *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 30
Exclusion criteria
Exclusion criteria: The study objective is to explore the effect of enzalutamide on biomarker exposure in a group of patients treated with enzalutamide in agreement with the drug label. Therefore no strict exclusion criteria will be used in this study.Additionally, patients are not allowed to be treated with other anti-cancer therapies, concomitant alternative therapies and herbal preparations that potentially affect enzalutamide exposure and strong CYP2C8 inhibitors and inducers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objectives: To explore whether the decrease in a panel of early easily assessable biomarkers (PSA-mRNA, PCA3-mRNA and TMPRSS2:ERG gene fusion-mRNA, (currently under development) ARv7 mRNA, ARwt mRNA, miR-21, miR-141, miR-200a, miRrumc95, miRrumc87 and miRrumc4417) can discriminate between patients who will develop 1. Objective response 2. Stable disease and 3 who are de novo resistant after 3 and 6 months of therapy. ;Secondary Objective: Secondary Objectives: - To explore the relation between enzalutamide & N-desmethylenzalutamide plasma exposure and the decrease in the se-lected biomarkers (the panel of mRNAs and microRNAs) - To explore the relation between selected biomarker response under enzalutamide therapy and radiographic progression free survival - To explore the relation between enzalutamide & N-desmethylenzalutamide exposure and radiographic progression free survival ;Primary end point(s): To describe the relation between (early)biomarker response (%) and therapeutical response (OR, SD, de novo resistent) ;Timepoint(s) of evaluation of this end point: Response Assessment: Day 84(±4d) ; Day 168(±4d) Biomarkers : Day 28(±2d) ; Day 84(±4d) ; Day 168(±4d) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To explore the relation between Enzalutamide&N-desmethylenzalutamide exposure (AUC) and decrease in biomarkers(%) from baseline - To describe the relation between biomarker response en rPFS - To describe the relation between (early) drug exposure and therapeutical response;Timepoint(s) of evaluation of this end point: Response Assessment: Day 84(±4d) ; Day 168(±4d) Biomarkers : Day 28(±2d) ; Day 84(±4d) ; Day 168(±4d) | — |
Countries
Netherlands
Contacts
Public ContactNielka van Erp
Radboud University Medical Center
Outcome results
None listed