Adenocarcinoma of prostate | Metastatic Lesion
Item
adenocarcinoma of prostate; if diagnosed greater than or equal to (>=) 5 years from randomization, histologic evidence of prostate adenocarcinoma from a metastatic lesion is required
boolean
C0007112 (UMLS CUI [1])
C1513183 (UMLS CUI [2])
Neoplasm Metastasis | Bone lesion Quantity Tc-99m Bone scan
Item
metastatic disease documented by >= 2 bone lesions on 99mtc bone scan
boolean
C0027627 (UMLS CUI [1])
C0238792 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0303611 (UMLS CUI [2,3])
C0203668 (UMLS CUI [2,4])
ECOG performance status
Item
eastern cooperative oncology group performance status (ecog ps) grade of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Prior Therapy Prostate carcinoma | Therapeutic radiology procedure Quantity | Surgical intervention Quantity | Docetaxel Course Quantity | Disease minor | Disease Progression Absent | Antiandrogen therapy Neoplasm Metastasis | Gonadotropin Releasing Hormone Agonist Adjuvant therapy | Gonadotropin Releasing Hormone Agonist Neoadjuvant Therapy | Therapeutic radiology procedure | Prostatectomy
Item
allowed prior treatment for prostate cancer: a) maximum of 1 course of radiation or surgical intervention; b) up to 6 cycles of docetaxel for low-volume disease with the last dose within 2 months of randomization; c) must not have experienced disease progression between the last dose of docetaxel and screening; d) participants who did not receive prior docetaxel may have received less than or equal to (<=) 3 months of adt in the metastatic disease setting prior to randomization. participants who received prior docetaxel may have received <= 6 months adt in the metastatic setting prior to randomization; e) may also have received up to 6 months of gnrha in the adjuvant or neo-adjuvant setting as long as it was completed greater than (>)1 year prior to randomization; f) may have received radiation therapy or prostatectomy as definitive therapy
boolean
C1514463 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0549433 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0246415 (UMLS CUI [4,1])
C0750729 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C1446899 (UMLS CUI [5,2])
C0242656 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0279492 (UMLS CUI [7,1])
C0027627 (UMLS CUI [7,2])
C2267073 (UMLS CUI [8,1])
C0677850 (UMLS CUI [8,2])
C2267073 (UMLS CUI [9,1])
C0600558 (UMLS CUI [9,2])
C1522449 (UMLS CUI [10])
C0033573 (UMLS CUI [11])
Small cell carcinoma of prostate | Ductal Carcinoma Prostate | Neuroendocrine Carcinoma Prostate
Item
pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
boolean
C1300585 (UMLS CUI [1])
C1176475 (UMLS CUI [2,1])
C0033572 (UMLS CUI [2,2])
C0206695 (UMLS CUI [3,1])
C0033572 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain
Item
known brain metastases
boolean
C0220650 (UMLS CUI [1])
Secondary malignant neoplasm of lymph node
Item
lymph nodes as only site of metastasis
boolean
C0686619 (UMLS CUI [1])
Neoplasm Metastasis Visceral CT | Neoplasm Metastasis Visceral MRI | Bone lesion Quantity Tc-99m Bone scan | Lesion Quantity Except Pelvis | Lesion Quantity Except Vertebral column
Item
visceral metastasis observed on computed tomography (ct)/magnetic resonance imaging (mri) or >= 4 bone lesions on 99mtc bone scan with at least 1 lesion beyond the pelvis or vertebral column
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0442045 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
C0238792 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0303611 (UMLS CUI [3,3])
C0203668 (UMLS CUI [3,4])
C0221198 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0332300 (UMLS CUI [4,3])
C0030797 (UMLS CUI [4,4])
C0221198 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0332300 (UMLS CUI [5,3])
C0037949 (UMLS CUI [5,4])
Malignant Neoplasms | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder Non-invasive
Item
any prior malignancy within 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0553723 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1336527 (UMLS CUI [4,2])
C0205303 (UMLS CUI [4,3])
Androgen Antagonists Generation second Prostate carcinoma | CYP17 Inhibitor Prostate carcinoma | Immunotherapy Prostate carcinoma | Radiopharmaceuticals Prostate carcinoma
Item
prior treatment with other second generation anti-androgens or other cyp17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer
boolean
C0002842 (UMLS CUI [1,1])
C0079411 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
C0600139 (UMLS CUI [1,4])
C3160096 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
C0182638 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
Seizures | Pharmaceutical Preparations Causing Lowered convulsive threshold
Item
history of seizures or medications known to lower seizure threshold
boolean
C0036572 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0234976 (UMLS CUI [2,3])