Informed consent
Item
1. written informed consent
boolean
C0021430 (UMLS CUI [1])
Adult | Adenocarcinoma of prostate
Item
2. adult patients with histological diagnosis of adenocarcinoma of the prostate.
boolean
C0001675 (UMLS CUI [1])
C0007112 (UMLS CUI [2])
Male Castration Resistant Metastatic Prostate Carcinoma
Item
3. metastatic castration-resistant prostate cancer (mcrpc)
boolean
C0007347 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0936223 (UMLS CUI [1,3])
Chemotherapy taxane | Disease Progression | Medical contraindication taxane | Therapeutic procedure Hormone preparation | Cytochrome P450 17A1 Inhibitor | Amino Acids | enzalutamide
Item
4. progression after at least one taxane-based chemotherapy (or contraindication against taxanes) and at least one therapy with a newer hormonal agent (cyp17 inhibitor or a new generation aa like enzalutamide).
boolean
C0392920 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0215136 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0019932 (UMLS CUI [4,2])
C3160096 (UMLS CUI [5])
C0002520 (UMLS CUI [6])
C3496793 (UMLS CUI [7])
PTEN Loss | Immunohistochemistry | Score Histologic | Defect in DNA repair | Next Generation Sequencing
Item
5. loss of pten by ihc (h-scores ≤ 30) and/or evidence of dna repair defects by ngs
boolean
C3272693 (UMLS CUI [1])
C0021044 (UMLS CUI [2])
C0449820 (UMLS CUI [3,1])
C0205462 (UMLS CUI [3,2])
C3278814 (UMLS CUI [4])
C2936622 (UMLS CUI [5])
ECOG performance status
Item
6. eastern cooperative oncology group (ecog) performance status (ps) 0 - 2
boolean
C1520224 (UMLS CUI [1])
Disease Progression
Item
7. progression of disease by any of the criteria listed here:
boolean
C0242656 (UMLS CUI [1])
Prostate specific antigen measurement
Item
psa utilizing pcwg 2 criteria
boolean
C0201544 (UMLS CUI [1])
Radioisotope scan of bone
Item
bone scan
boolean
C0203668 (UMLS CUI [1])
RECIST
Item
recist 1.1
boolean
C1709926 (UMLS CUI [1])
organ function | Bone Marrow physiological aspects
Item
8. adequate organ and bone marrow function as evidenced by:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Hemoglobin measurement
Item
haemoglobin ≥8.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count ≥1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100 x 109/l
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
ast and/or alt < 2.5 x uln, in the presence of liver metastases: ast ≥5 x uln, alt <5 x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Bilirubin, total measurement | Gilbert Disease
Item
total bilirubin < 2.0 x uln (except for patients with gilbert's disease)
boolean
C0201913 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
Creatinine clearance measurement
Item
creatinine clearance ≥30ml/min
boolean
C0373595 (UMLS CUI [1])
Agree Biological Markers Clinical study | Malignant Neoplasm Biopsy Fresh Specimen
Item
9. patient must agree in the biomarker studies including the fresh tumour biopsies
boolean
C3641827 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C2827486 (UMLS CUI [2,3])
Medical contraindication Class of Trial Agent | Hypersensitivity Class of Trial Agent | Hypersensitivity Carboplatin
Item
1. contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product carboplatin
boolean
C1301624 (UMLS CUI [1,1])
C2983595 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2983595 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0079083 (UMLS CUI [3,2])
Prior Therapy | Prior Chemotherapy Platinum-Based
Item
2. prior treatment with any prior platinum based chemotherapy,
boolean
C1514463 (UMLS CUI [1])
C1514457 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
major surgery
Item
3. major surgery within 4 weeks prior to planned start of treatment
boolean
C0679637 (UMLS CUI [1])
Brain Involvement with | Leptomeninges Involvement with | Stable status Clinical | Steroids Dosage Stable status
Item
4. known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids
boolean
C0006104 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0228126 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0205360 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
C0038317 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Study Protocol Compliance behavior Unable | problem; language | Mental disorders | Dementia
Item
5. inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
boolean
C2348563 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1405458 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
Study Subject Participation Status
Item
6. previous enrolment into the current study
boolean
C2348568 (UMLS CUI [1])
Secondary Malignant Neoplasm Requirement systemic therapy
Item
7. active secondary malignancy that requires systemic therapy.
boolean
C3266877 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])