Adenocarcinoma of prostate | Indication Radical retropubic prostatectomy Curative
Item
histologic evidence of adenocarcinoma of the prostate deemed candidates for curative rrp
boolean
C0007112 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0194825 (UMLS CUI [2,2])
C1276305 (UMLS CUI [2,3])
Local disease Intermediate Risk | Local disease High risk
Item
intermediate or high risk, clinically localized disease
boolean
C0277565 (UMLS CUI [1,1])
C3640764 (UMLS CUI [1,2])
C0277565 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
Organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Male sterilization | Contraceptive methods
Item
patients must be surgically sterile or must agree to use effective contraception during the period of therapy
boolean
C0024559 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Indication Imaging | Neoplasm Metastasis Exclude
Item
select imaging to rule out metastasis will be done as clinically indicated
boolean
C3146298 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Informed Consent
Item
signed and date informed consent document
boolean
C0021430 (UMLS CUI [1])
Therapeutic procedure Prostate carcinoma
Item
prior treatment for prostate cancer
boolean
C0087111 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Major surgery | Therapeutic radiology procedure
Item
major surgery or radiation therapy within 4 weeks of starting the study treatment
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Hemorrhage CTCAE Grades
Item
nci ctcae grade 3 hemorrhage within 4 weeks of starting therapy
boolean
C0019080 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Metastatic Prostate Carcinoma
Item
history of or known metastatic prostate cancer
boolean
C0936223 (UMLS CUI [1])
Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral artery bypass | Symptomatic congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism
Item
any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C3495795 (UMLS CUI [5])
C0742758 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
C0007787 (UMLS CUI [8])
C0034065 (UMLS CUI [9])
Cardiac Arrhythmia CTCAE Grades
Item
ongoing cardiac dysrhythmias of nci ctcae grade 2 or greater
boolean
C0003811 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Prolonged QTc interval on electrocardiogram (ECG)
Item
qtc interval > 500 msec on baseline ekg
boolean
C4015677 (UMLS CUI [1])
Uncontrolled hypertension | Therapeutic procedure Optimal
Item
hypertension that cannot be controlled by medications (>150/100 mm hg despite optimal medical therapy).
boolean
C1868885 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2698651 (UMLS CUI [2,2])
Thyroid Disease Pre-existing | Thyroid function decreased | Pharmaceutical Preparations failed
Item
pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
boolean
C0040128 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0858730 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
Communicable Disease
Item
known active infection
boolean
C0009450 (UMLS CUI [1])
Study Subject Participation Status | Therapeutic procedure | Supportive care | Quality of life
Item
concurrent treatment on another clinical trial. supportive care trials or non-treatment trials, e.g. qol, are allowed.
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0344211 (UMLS CUI [3])
C0034380 (UMLS CUI [4])
Medical condition Severe | Mental disorder Severe | Laboratory test result abnormal | Study Subject Participation Status Risk Increase | Investigational New Drugs Risk Increase | Medical condition Interferes with Interpretation Research results | Study Subject Participation Status Inappropriate
Item
other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0438215 (UMLS CUI [3])
C2348568 (UMLS CUI [4,1])
C0035647 (UMLS CUI [4,2])
C0442805 (UMLS CUI [4,3])
C0013230 (UMLS CUI [5,1])
C0035647 (UMLS CUI [5,2])
C0442805 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0459471 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C2348568 (UMLS CUI [7,1])
C1548788 (UMLS CUI [7,2])