ID

36972

Description

An Efficacy and Safety Study of JNJ56021927 in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC); ODM derived from: https://clinicaltrials.gov/show/NCT02257736

Link

https://clinicaltrials.gov/show/NCT02257736

Keywords

Versions (1)
  1. 6/25/19 6/25/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 25, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT02257736

English

Eligibility Prostatic Neoplasms NCT02257736

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adenocarcinoma of the prostate
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0303611
UMLS CUI [1,3]
C0203668
UMLS CUI [2,1]
C1513183
UMLS CUI [2,2]
C0040405
UMLS CUI [3,1]
C1513183
UMLS CUI [3,2]
C0024485
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0442045
UMLS CUI [5]
C0272394
UMLS CUI [6,1]
C0686619
UMLS CUI [6,2]
C0552406
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)
Description

Hormone refractory prostate cancer | Antiandrogen therapy | Raised prostate specific antigen Quantity | Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C1328504
UMLS CUI [2]
C0279492
UMLS CUI [3,1]
C0178415
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0201544
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
Description

Androgen Antagonists Generation First | bicalutamide | Flutamide | nilutamide | Disease Progression | Raised prostate specific antigen | Status post Washout Period

Data type

boolean

Alias
UMLS CUI [1,1]
C0002842
UMLS CUI [1,2]
C0079411
UMLS CUI [1,3]
C0205435
UMLS CUI [2]
C0285590
UMLS CUI [3]
C0016384
UMLS CUI [4]
C0068771
UMLS CUI [5]
C0242656
UMLS CUI [6]
C0178415
UMLS CUI [7,1]
C0231290
UMLS CUI [7,2]
C1710661
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
Description

Progression of prostate cancer Prostate specific antigen measurement | Disease Progression Soft tissue Radiography | Disease Progression Bone Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C1739135
UMLS CUI [1,2]
C0201544
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0225317
UMLS CUI [2,3]
C0034571
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0262950
UMLS CUI [3,3]
C0034571
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
small cell or neuroendocrine carcinoma of the prostate
Description

Small cell carcinoma of prostate | Prostate carcinoma Neuroendocrine Differentiation

Data type

boolean

Alias
UMLS CUI [1]
C1300585
UMLS CUI [2,1]
C0600139
UMLS CUI [2,2]
C1709218
known brain metastases
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting
Description

Prior Chemotherapy Prostate carcinoma | Exception Adjuvant therapy | Exception Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0677850
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0600558
previously treated with ketoconazole for prostate cancer for greater than 7 days
Description

Ketoconazole Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0022625
UMLS CUI [1,2]
C0600139
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1272691
UMLS CUI [2]
C1141862
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C0234976
UMLS CUI [4,1]
C2240391
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C0178414
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0678227
UMLS CUI [5,3]
C0178414
UMLS CUI [6]
C0771607
UMLS CUI [7]
C1961993
UMLS CUI [8]
C0013230
at screening need for parenteral or oral opioid analgesics (eg, codeine, dextropropoxyphene)
Description

Patient need for Opioid Analgesics Parenteral | Patient need for Opioid Analgesics Oral | Codeine | Propoxyphene

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0002772
UMLS CUI [1,3]
C1518896
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0002772
UMLS CUI [2,3]
C1527415
UMLS CUI [3]
C0009214
UMLS CUI [4]
C0033493
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Similar models

Eligibility Prostatic Neoplasms NCT02257736

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