Informed Consent
Item
1. provision of written informed consent
boolean
C0021430 (UMLS CUI [1])
TNM clinical staging Biopsy | TNM clinical staging Bone scan | TNM clinical staging CT | TNM clinical staging MRI
Item
2. t2c-t3b n0 m0 (biopsy、 bone scan、 ct、 mri)
boolean
C3258246 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2,1])
C0203668 (UMLS CUI [2,2])
C3258246 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
C3258246 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
Neoplasm Metastasis Absent Bone scan | Neoplasm Metastasis Absent CT | Neoplasm Metastasis Absent MRI
Item
3. no metastasis (bone scan、 ct、 mri)
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0203668 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
Prostate specific antigen measurement
Item
4. psa level>10ng/ml
boolean
C0201544 (UMLS CUI [1])
Prostate carcinoma
Item
5. histological or cytological confirmation of prostate cancer
boolean
C0600139 (UMLS CUI [1])
Comprehension Study Protocol | Protocol Compliance
Item
6. able to understand and comply with the requirements of the study
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
External beam radiotherapy | Chemotherapy
Item
1. having been treated with external radiation therapy or chemistry therapy.
boolean
C0419095 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Disease Clinical Relevant | Abnormality Clinical Relevant | Cardiovascular Diseases | Kidney Diseases | Liver diseases | Malignant Neoplasms | Gastrointestinal Diseases | Other medical condition Affecting Drug absorption | Other medical condition Affecting Drug elimination
Item
2. clinical relevant disease and/or abnormalities (past or present), eg, significant cardiovascular, renal or liver disease, malignancy, gastro-intestinal disorders, or other conditions which could affect the absorption/elimination of drugs.
boolean
C0012634 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C2347946 (UMLS CUI [2,3])
C0007222 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0006826 (UMLS CUI [6])
C0017178 (UMLS CUI [7])
C3843040 (UMLS CUI [8,1])
C0392760 (UMLS CUI [8,2])
C0678745 (UMLS CUI [8,3])
C3843040 (UMLS CUI [9,1])
C0392760 (UMLS CUI [9,2])
C0683141 (UMLS CUI [9,3])
Alanine aminotransferase increased | Aspartate aminotransferase increased | Study Subject Participation Status Unfavorable
Item
3. alanine amino transferase (alt) or aspartate amino transferase (ast) greater than 2 times the upper limit of normal (uln) at screening findings that make it undesirable for the patient to participate in the study in the opinion of the investigator(s)
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C2348568 (UMLS CUI [3,1])
C3640815 (UMLS CUI [3,2])
Systemic disease Severe | Systemic disease Uncontrolled | Respiration Disorder Unstable | Heart Disease Unstable | Liver disease Unstable | Kidney Disease Unstable | Respiration Disorder Without Resolution | Heart Disease Without Resolution | Liver disease Without Resolution | Kidney Disease Without Resolution
Item
4. in the opinion of the investigator(s), any evidence of severe or uncontrolled systemic disease (eg, currently unstable or unresolved respiratory, cardiac, hepatic, or renal disease).
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0035204 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0023895 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0035204 (UMLS CUI [7,1])
C0332288 (UMLS CUI [7,2])
C1514893 (UMLS CUI [7,3])
C0018799 (UMLS CUI [8,1])
C0332288 (UMLS CUI [8,2])
C1514893 (UMLS CUI [8,3])
C0023895 (UMLS CUI [9,1])
C0332288 (UMLS CUI [9,2])
C1514893 (UMLS CUI [9,3])
C0022658 (UMLS CUI [10,1])
C0332288 (UMLS CUI [10,2])
C1514893 (UMLS CUI [10,3])
Medical contraindication GnRH antagonist | Hypersensitivity GnRH antagonist | Hypersensitivity Suspected GnRH antagonist | Medical contraindication GnRH Excipient | Hypersensitivity GnRH Excipient | Hypersensitivity Suspected GnRH Excipient
Item
5. contra-indications (eg, known or suspected allergy) to gnrh antagonists or excipients(non-active ingredients of investigational product).
boolean
C1301624 (UMLS CUI [1,1])
C1268855 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1268855 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C1268855 (UMLS CUI [3,3])
C1301624 (UMLS CUI [4,1])
C0023610 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0023610 (UMLS CUI [5,2])
C0015237 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C0023610 (UMLS CUI [6,3])
C0015237 (UMLS CUI [6,4])
Drugs, Non-Prescription | Investigational New Drugs
Item
6. treatment with a non-approved or investigational drug within 30 days before study entry.
boolean
C0013231 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Substance Use Disorders
Item
7. bibulosity or drug abuse.
boolean
C0038586 (UMLS CUI [1])