ID

36952

Description

A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC); ODM derived from: https://clinicaltrials.gov/show/NCT02384382

Link

https://clinicaltrials.gov/show/NCT02384382

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 Carcinoma Metastatic to the Bone NCT02384382

English

Eligibility Prostate Carcinoma Metastatic to the Bone NCT02384382

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, or signet cell or small cell features;
Description

Adenocarcinoma of prostate | Neuroendocrine Differentiation Absent | Signet ring cell Feature Absent | Feature Cells Small Absent

Data type

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2,1]
C1709218
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0333727
UMLS CUI [3,2]
C2348519
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C2348519
UMLS CUI [4,2]
C0007634
UMLS CUI [4,3]
C0700321
UMLS CUI [4,4]
C0332197
presence of bone metastatic disease as assessed by at least two lesions on whole body metastable technetium-methylene diphosphonate (99mtc-mdp) bone scintigraphy;
Description

Secondary malignant neoplasm of bone | Lesion Quantity | Whole body Technetium Tc 99m Medronate Bone scintigraphy

Data type

boolean

Alias
UMLS CUI [1]
C0153690
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0444584
UMLS CUI [3,2]
C0039416
UMLS CUI [3,3]
C3889015
throughout the study, ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (lhrh) analogue or prior bilateral orchiectomy (medical or surgical castration);
Description

Antiandrogen therapy | Luteinizing Hormone-releasing Hormone Agonist | Medical Castration | Male Castration

Data type

boolean

Alias
UMLS CUI [1]
C0279492
UMLS CUI [2]
C1518041
UMLS CUI [3]
C1513054
UMLS CUI [4]
C0007347
testosterone ≤ 1.73 nmol/l (≤ 50 ng/dl) at screening;
Description

Testosterone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0523912
progressive disease on androgen deprivation therapy at screening defined as a minimum of two sequentially rising prostate-specific antigen (psa) values;
Description

Progressive Disease | Antiandrogen therapy | Raised prostate specific antigen Result Quantity

Data type

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2]
C0279492
UMLS CUI [3,1]
C0178415
UMLS CUI [3,2]
C1274040
UMLS CUI [3,3]
C1265611
both the most recent local psa and the initial screening psa must be ≥ 2 µg/l (≥ 2 ng/ml).
Description

Prostate specific antigen measurement Local | Prostate specific antigen measurement Screening Initial

Data type

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C0205276
UMLS CUI [2,1]
C0201544
UMLS CUI [2,2]
C0220908
UMLS CUI [2,3]
C0205265
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior enzalutamide, abiraterone acetate, aminoglutethimide, ketoconazole, radium ra 223 dichloride or other bone-targeting radionuclides, or cytotoxic chemotherapy in the crpc setting for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo);
Description

enzalutamide | abiraterone acetate | Aminoglutethimide | Ketoconazole | Radium Ra-223 Dichloride | Radionuclides Targeting Bone | Cytotoxic Chemotherapy | Hormone refractory prostate cancer | Therapy Prostate carcinoma | Study Subject Participation Status | Investigational New Drugs | Androgen Antagonists | Androgen Synthesis Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C3496793
UMLS CUI [2]
C2607886
UMLS CUI [3]
C0002555
UMLS CUI [4]
C0022625
UMLS CUI [5]
C3541342
UMLS CUI [6,1]
C0034595
UMLS CUI [6,2]
C1521840
UMLS CUI [6,3]
C0262950
UMLS CUI [7]
C0677881
UMLS CUI [8]
C1328504
UMLS CUI [9,1]
C0087111
UMLS CUI [9,2]
C0600139
UMLS CUI [10]
C2348568
UMLS CUI [11]
C0013230
UMLS CUI [12]
C0002842
UMLS CUI [13]
C3853002
treatment with hormonal therapy (eg, androgen receptor inhibitors, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than lhrh analogue therapy) within 4 weeks before enrollment;
Description

Hormone Therapy Prostate carcinoma | Androgen Antagonists | 5-alpha Reductase Inhibitors | Biological treatment Prostate carcinoma | Exception Luteinizing Hormone-releasing Hormone Agonist

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C0002842
UMLS CUI [3]
C2936788
UMLS CUI [4,1]
C1531518
UMLS CUI [4,2]
C0600139
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1518041
initiation of new treatment with denosumab, bisphosphonates, or systemic corticosteroids for treatment of prostate cancer within 4 weeks before enrollment;
Description

New therapy Prostate carcinoma | denosumab | Diphosphonates | CORTICOSTEROIDS FOR SYSTEMIC USE

Data type

boolean

Alias
UMLS CUI [1,1]
C3242274
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C1690432
UMLS CUI [3]
C0012544
UMLS CUI [4]
C3653708
use of an investigational agent within 4 weeks before the screening visit;
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
radiation therapy to bone within 4 weeks before enrollment;
Description

Radiotherapy to bone

Data type

boolean

Alias
UMLS CUI [1]
C0948797
use of opiate analgesics for prostate cancer pain within 4 weeks before enrollment;
Description

Use of Opiate Analgesics | Prostate carcinoma Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0376196
UMLS CUI [1,3]
C0002771
UMLS CUI [2,1]
C0600139
UMLS CUI [2,2]
C0030193
screening 99mtc-mdp bone scintigraphy showing a superscan;
Description

Technetium Tc 99m Medronate Bone scintigraphy | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0039416
UMLS CUI [1,2]
C3889015
UMLS CUI [2]
C3846158
visceral (eg, lung, liver) metastatic disease. adenopathy is allowed;
Description

Neoplasm Metastasis Visceral | Secondary malignant neoplasm of lung | Secondary malignant neoplasm of liver | Adenopathy allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442045
UMLS CUI [2]
C0153676
UMLS CUI [3]
C0494165
UMLS CUI [4,1]
C0497156
UMLS CUI [4,2]
C0683607
current or previously treated brain metastasis or active leptomeningeal disease;
Description

Metastatic malignant neoplasm to brain Treated | Leptomeningeal disease Treated

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C0751297
UMLS CUI [2,2]
C1522326
history of seizure any time in the past for any reason or any condition that may predispose to seizures.
Description

Seizures | Predisposing Factor Seizures

Data type

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2,1]
C0032946
UMLS CUI [2,2]
C0036572
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Similar models

Eligibility Prostate Carcinoma Metastatic to the Bone NCT02384382

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate | Neuroendocrine Differentiation Absent | Signet ring cell Feature Absent | Feature Cells Small Absent
Item
histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, or signet cell or small cell features;
boolean
C0007112 (UMLS CUI [1])
C1709218 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0333727 (UMLS CUI [3,1])
C2348519 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C2348519 (UMLS CUI [4,1])
C0007634 (UMLS CUI [4,2])
C0700321 (UMLS CUI [4,3])
C0332197 (UMLS CUI [4,4])
Secondary malignant neoplasm of bone | Lesion Quantity | Whole body Technetium Tc 99m Medronate Bone scintigraphy
Item
presence of bone metastatic disease as assessed by at least two lesions on whole body metastable technetium-methylene diphosphonate (99mtc-mdp) bone scintigraphy;
boolean
C0153690 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0444584 (UMLS CUI [3,1])
C0039416 (UMLS CUI [3,2])
C3889015 (UMLS CUI [3,3])
Antiandrogen therapy | Luteinizing Hormone-releasing Hormone Agonist | Medical Castration | Male Castration
Item
throughout the study, ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (lhrh) analogue or prior bilateral orchiectomy (medical or surgical castration);
boolean
C0279492 (UMLS CUI [1])
C1518041 (UMLS CUI [2])
C1513054 (UMLS CUI [3])
C0007347 (UMLS CUI [4])
Testosterone measurement
Item
testosterone ≤ 1.73 nmol/l (≤ 50 ng/dl) at screening;
boolean
C0523912 (UMLS CUI [1])
Progressive Disease | Antiandrogen therapy | Raised prostate specific antigen Result Quantity
Item
progressive disease on androgen deprivation therapy at screening defined as a minimum of two sequentially rising prostate-specific antigen (psa) values;
boolean
C1335499 (UMLS CUI [1])
C0279492 (UMLS CUI [2])
C0178415 (UMLS CUI [3,1])
C1274040 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Prostate specific antigen measurement Local | Prostate specific antigen measurement Screening Initial
Item
both the most recent local psa and the initial screening psa must be ≥ 2 µg/l (≥ 2 ng/ml).
boolean
C0201544 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
C0205265 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
enzalutamide | abiraterone acetate | Aminoglutethimide | Ketoconazole | Radium Ra-223 Dichloride | Radionuclides Targeting Bone | Cytotoxic Chemotherapy | Hormone refractory prostate cancer | Therapy Prostate carcinoma | Study Subject Participation Status | Investigational New Drugs | Androgen Antagonists | Androgen Synthesis Inhibitors
Item
prior enzalutamide, abiraterone acetate, aminoglutethimide, ketoconazole, radium ra 223 dichloride or other bone-targeting radionuclides, or cytotoxic chemotherapy in the crpc setting for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo);
boolean
C3496793 (UMLS CUI [1])
C2607886 (UMLS CUI [2])
C0002555 (UMLS CUI [3])
C0022625 (UMLS CUI [4])
C3541342 (UMLS CUI [5])
C0034595 (UMLS CUI [6,1])
C1521840 (UMLS CUI [6,2])
C0262950 (UMLS CUI [6,3])
C0677881 (UMLS CUI [7])
C1328504 (UMLS CUI [8])
C0087111 (UMLS CUI [9,1])
C0600139 (UMLS CUI [9,2])
C2348568 (UMLS CUI [10])
C0013230 (UMLS CUI [11])
C0002842 (UMLS CUI [12])
C3853002 (UMLS CUI [13])
Hormone Therapy Prostate carcinoma | Androgen Antagonists | 5-alpha Reductase Inhibitors | Biological treatment Prostate carcinoma | Exception Luteinizing Hormone-releasing Hormone Agonist
Item
treatment with hormonal therapy (eg, androgen receptor inhibitors, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than lhrh analogue therapy) within 4 weeks before enrollment;
boolean
C0279025 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0002842 (UMLS CUI [2])
C2936788 (UMLS CUI [3])
C1531518 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1518041 (UMLS CUI [5,2])
New therapy Prostate carcinoma | denosumab | Diphosphonates | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
initiation of new treatment with denosumab, bisphosphonates, or systemic corticosteroids for treatment of prostate cancer within 4 weeks before enrollment;
boolean
C3242274 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1690432 (UMLS CUI [2])
C0012544 (UMLS CUI [3])
C3653708 (UMLS CUI [4])
Investigational New Drugs
Item
use of an investigational agent within 4 weeks before the screening visit;
boolean
C0013230 (UMLS CUI [1])
Radiotherapy to bone
Item
radiation therapy to bone within 4 weeks before enrollment;
boolean
C0948797 (UMLS CUI [1])
Use of Opiate Analgesics | Prostate carcinoma Pain
Item
use of opiate analgesics for prostate cancer pain within 4 weeks before enrollment;
boolean
C1524063 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
C0002771 (UMLS CUI [1,3])
C0600139 (UMLS CUI [2,1])
C0030193 (UMLS CUI [2,2])
Technetium Tc 99m Medronate Bone scintigraphy | Other Coding
Item
screening 99mtc-mdp bone scintigraphy showing a superscan;
boolean
C0039416 (UMLS CUI [1,1])
C3889015 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Neoplasm Metastasis Visceral | Secondary malignant neoplasm of lung | Secondary malignant neoplasm of liver | Adenopathy allowed
Item
visceral (eg, lung, liver) metastatic disease. adenopathy is allowed;
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C0153676 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
C0497156 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Metastatic malignant neoplasm to brain Treated | Leptomeningeal disease Treated
Item
current or previously treated brain metastasis or active leptomeningeal disease;
boolean
C0220650 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0751297 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Seizures | Predisposing Factor Seizures
Item
history of seizure any time in the past for any reason or any condition that may predispose to seizures.
boolean
C0036572 (UMLS CUI [1])
C0032946 (UMLS CUI [2,1])
C0036572 (UMLS CUI [2,2])
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