Adenocarcinoma of prostate | No evidence of Neuroendocrine Differentiation
Item
histologically or cytologically confirmed adenocarcinoma of the prostate. no evidence of neuroendocrine differentiation or small cell features.
boolean
C0007112 (UMLS CUI [1])
C0332125 (UMLS CUI [2,1])
C1709218 (UMLS CUI [2,2])
Castration | Medical Castration | Testosterone measurement
Item
surgically or medically castrated, with testosterone ≤ 50 ng/dl (≤ 1.7 nmol/l).
boolean
C0007344 (UMLS CUI [1])
C1513054 (UMLS CUI [2])
C0523912 (UMLS CUI [3])
Prostate carcinoma Progressive | Prostate specific antigen measurement | Disorder of soft tissue | Bone Diseases
Item
progressive prostate cancer by either serum psa levels, soft tissue or bone disease as defined by the pcwg2 criteria.
boolean
C0600139 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2])
C0263978 (UMLS CUI [3])
C0005940 (UMLS CUI [4])
Prior Chemotherapy | Prostatic Cancer, Castration-Resistant Metastatic | abiraterone | enzalutamide
Item
in stage 1, patients may or may not have received prior chemotherapy for mcrpc. in stage 2, patients will be enrolled into two cohorts based on whether or not they have received prior chemotherapy for mcrpc. any prior chemotherapy must have been completed ≥ 4 weeks prior to administration of es414. additionally, in countries where abiraterone or enzalutamide are commercially available, patients in stage 1 and 2 must have progressed on abiraterone and/or enzalutamide prior to study entry.
boolean
C1514457 (UMLS CUI [1])
C3658266 (UMLS CUI [2,1])
C0036525 (UMLS CUI [2,2])
C0754011 (UMLS CUI [3])
C3496793 (UMLS CUI [4])
ECOG performance status
Item
ecog ≤ 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 6 months per investigator
boolean
C0023671 (UMLS CUI [1])
Hematologic function | Renal function | Liver function
Item
adequate hematologic, renal, and hepatic parameters
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Chemotherapy | Investigational New Drugs
Item
any chemotherapy or investigational drug in prior 4 weeks
boolean
C0392920 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Therapeutic radiology procedure
Item
any radiation therapy in prior 2 weeks
boolean
C1522449 (UMLS CUI [1])
Targeted Therapy Previous Against prostate-specific membrane antigen
Item
any prior therapy targeted against psma
boolean
C2985566 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0521124 (UMLS CUI [1,3])
C1310550 (UMLS CUI [1,4])
Seizures
Item
history of seizures
boolean
C0036572 (UMLS CUI [1])
CNS metastases
Item
history of central nervous system metastasis
boolean
C0686377 (UMLS CUI [1])
Nephrotic Syndrome
Item
history of nephrotic syndrome
boolean
C0027726 (UMLS CUI [1])
Urine total protein measurement Spot urine sample | Creatinine measurement, serum | Ratio
Item
spot urine total protein:creatinine ratio >1,000 mg/gm
boolean
C0428541 (UMLS CUI [1,1])
C0457208 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C0456603 (UMLS CUI [3])
Palliative procedure Planned | Bone pain
Item
planned palliative procedures for alleviation of bone pain
boolean
C1285158 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0151825 (UMLS CUI [2])
Communicable Diseases | Therapeutic procedure Anti-Infective Agents Systemic | major surgery
Item
active infection requiring treatment with systemic anti-infectives or major surgery in prior 4 weeks.
boolean
C0009450 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0003204 (UMLS CUI [2,2])
C0205373 (UMLS CUI [2,3])
C0679637 (UMLS CUI [3])
Prednisone | Adrenal Cortex Hormones equivalent
Item
any prednisone (or equivalent corticosteroids) use within 4 weeks of study entry
boolean
C0032952 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C3242703 (UMLS CUI [2,2])
Therapeutic immunosuppression chronic
Item
chronic immunosuppressive therapy
boolean
C0021079 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
HIV | Hepatitis B | Hepatitis C
Item
known history of hiv, hepatitis b, or hepatitis c infection
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Systemic disease Severe | Systemic disease Uncontrolled
Item
evidence of severe or uncontrolled systemic diseases
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Blood Coagulation Disorders | Thromboembolism
Item
history of bleeding disorders or thromboembolic events in prior 3 months
boolean
C0005779 (UMLS CUI [1])
C0040038 (UMLS CUI [2])