ID

36946

Description

A Study of JNJ-56021927 Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With Low-Volume mHSPC; ODM derived from: https://clinicaltrials.gov/show/NCT02489318

Link

https://clinicaltrials.gov/show/NCT02489318

Keywords

Versions (1)
  1. 6/23/19 6/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02489318

English

Eligibility Prostate Cancer NCT02489318

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
Description

Adenocarcinoma of prostate | Metastatic Lesion

Data type

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2]
C1513183
metastatic disease documented by >= 2 bone lesions on 99mtc bone scan
Description

Neoplasm Metastasis | Bone lesion Quantity Tc-99m Bone scan

Data type

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0238792
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0303611
UMLS CUI [2,4]
C0203668
eastern cooperative oncology group performance status (ecog ps) grade of 0, 1, or 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0549433
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0246415
UMLS CUI [4,2]
C0750729
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1446899
UMLS CUI [6,1]
C0242656
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0279492
UMLS CUI [7,2]
C0027627
UMLS CUI [8,1]
C2267073
UMLS CUI [8,2]
C0677850
UMLS CUI [9,1]
C2267073
UMLS CUI [9,2]
C0600558
UMLS CUI [10]
C1522449
UMLS CUI [11]
C0033573
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
Description

Small cell carcinoma of prostate | Ductal Carcinoma Prostate | Neuroendocrine Carcinoma Prostate

Data type

boolean

Alias
UMLS CUI [1]
C1300585
UMLS CUI [2,1]
C1176475
UMLS CUI [2,2]
C0033572
UMLS CUI [3,1]
C0206695
UMLS CUI [3,2]
C0033572
known brain metastases
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
lymph nodes as only site of metastasis
Description

Secondary malignant neoplasm of lymph node

Data type

boolean

Alias
UMLS CUI [1]
C0686619
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
Description

Neoplasm Metastasis Visceral CT | Neoplasm Metastasis Visceral MRI | Bone lesion Quantity Tc-99m Bone scan | Lesion Quantity Except Pelvis | Lesion Quantity Except Vertebral column

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442045
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0442045
UMLS CUI [2,3]
C0024485
UMLS CUI [3,1]
C0238792
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0303611
UMLS CUI [3,4]
C0203668
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0332300
UMLS CUI [4,4]
C0030797
UMLS CUI [5,1]
C0221198
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0332300
UMLS CUI [5,4]
C0037949
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
Description

Malignant Neoplasms | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder Non-invasive

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0553723
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1336527
UMLS CUI [4,3]
C0205303
prior treatment with other second generation anti-androgens or other cyp17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer
Description

Androgen Antagonists Generation second Prostate carcinoma | CYP17 Inhibitor Prostate carcinoma | Immunotherapy Prostate carcinoma | Radiopharmaceuticals Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0002842
UMLS CUI [1,2]
C0079411
UMLS CUI [1,3]
C0205436
UMLS CUI [1,4]
C0600139
UMLS CUI [2,1]
C3160096
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0600139
UMLS CUI [4,1]
C0182638
UMLS CUI [4,2]
C0600139
history of seizures or medications known to lower seizure threshold
Description

Seizures | Pharmaceutical Preparations Causing Lowered convulsive threshold

Data type

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0234976
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Similar models

Eligibility Prostate Cancer NCT02489318

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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