Adenocarcinoma of prostate
Item
adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Neoplasm Metastasis Tc 99m Bone scan | Metastatic Lesion Computed Tomography | Metastatic Lesion Magnetic Resonance Imaging | Disease Visceral | Disorder of lymph node | Secondary malignant neoplasm of lymph node Longest Diameter
Item
metastatic disease as documented by technetium-99m (99mtc) bone scan or metastatic lesions by computed tomography (ct) or magnetic resonance imaging (mri) scans (visceral or lymph node disease). if lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to (>=) 2 centimeter (cm) in the longest diameter
boolean
C0027627 (UMLS CUI [1,1])
C0303611 (UMLS CUI [1,2])
C0203668 (UMLS CUI [1,3])
C1513183 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C1513183 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0442045 (UMLS CUI [4,2])
C0272394 (UMLS CUI [5])
C0686619 (UMLS CUI [6,1])
C0552406 (UMLS CUI [6,2])
Hormone refractory prostate cancer | Antiandrogen therapy | Raised prostate specific antigen Quantity | Prostate specific antigen measurement
Item
castration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (adt), defined as 3 rises of psa, at least 1 week apart with the last androgen deprivation therapy (psa) >= 2 nanogram per milliliters (ng/ml)
boolean
C1328504 (UMLS CUI [1])
C0279492 (UMLS CUI [2])
C0178415 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0201544 (UMLS CUI [4])
Androgen Antagonists Generation First | bicalutamide | Flutamide | nilutamide | Disease Progression | Raised prostate specific antigen | Status post Washout Period
Item
participants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (psa) progression (an increase in psa) after the washout period
boolean
C0002842 (UMLS CUI [1,1])
C0079411 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0285590 (UMLS CUI [2])
C0016384 (UMLS CUI [3])
C0068771 (UMLS CUI [4])
C0242656 (UMLS CUI [5])
C0178415 (UMLS CUI [6])
C0231290 (UMLS CUI [7,1])
C1710661 (UMLS CUI [7,2])
Progression of prostate cancer Prostate specific antigen measurement | Disease Progression Soft tissue Radiography | Disease Progression Bone Radiography
Item
prostate cancer progression documented by prostate-specific antigen (psa) according to the prostate cancer clinical trials working group (pcwg2) or radiographic progression of soft tissue according to modified response evaluation criteria in solid tumors, version 1.1 (recist) modified based on pcwg2, or radiographic progression of bone according to pcwg2
boolean
C1739135 (UMLS CUI [1,1])
C0201544 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2,1])
C0225317 (UMLS CUI [2,2])
C0034571 (UMLS CUI [2,3])
C0242656 (UMLS CUI [3,1])
C0262950 (UMLS CUI [3,2])
C0034571 (UMLS CUI [3,3])
Small cell carcinoma of prostate | Prostate carcinoma Neuroendocrine Differentiation
Item
small cell or neuroendocrine carcinoma of the prostate
boolean
C1300585 (UMLS CUI [1])
C0600139 (UMLS CUI [2,1])
C1709218 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain
Item
known brain metastases
boolean
C0220650 (UMLS CUI [1])
Prior Chemotherapy Prostate carcinoma | Exception Adjuvant therapy | Exception Neoadjuvant Therapy
Item
prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting
boolean
C1514457 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
Ketoconazole Prostate carcinoma
Item
previously treated with ketoconazole for prostate cancer for greater than 7 days
boolean
C0022625 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Therapeutic procedure To be stopped | Therapy changed | Pharmaceutical Preparations Causing Lowered convulsive threshold | Herbal medicine (product) Causing Prostatic specific antigen decreased | Pharmaceutical Preparations Causing Prostatic specific antigen decreased | Saw palmetto extract | Pomegranate Extract | Investigational New Drugs
Item
therapies that must be discontinued or substituted at least 4 weeks prior to randomization include the following: a) medications known to lower the seizure threshold, b) herbal and non-herbal products that may decrease psa levels (example [eg], saw palmetto, pomegranate) or c) any investigational agent
boolean
C0087111 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C1141862 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0234976 (UMLS CUI [3,3])
C2240391 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C0178414 (UMLS CUI [4,3])
C0013227 (UMLS CUI [5,1])
C0678227 (UMLS CUI [5,2])
C0178414 (UMLS CUI [5,3])
C0771607 (UMLS CUI [6])
C1961993 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
Patient need for Opioid Analgesics Parenteral | Patient need for Opioid Analgesics Oral | Codeine | Propoxyphene
Item
at screening need for parenteral or oral opioid analgesics (eg, codeine, dextropropoxyphene)
boolean
C0686904 (UMLS CUI [1,1])
C0002772 (UMLS CUI [1,2])
C1518896 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0002772 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
C0009214 (UMLS CUI [3])
C0033493 (UMLS CUI [4])