ID

36967

Description

Standard Dose Versus High Dose and Versus Extended Standard Dose Radium-223 Dichloride in Castration-resistant Prostate Cancer Metastatic to the Bone; ODM derived from: https://clinicaltrials.gov/show/NCT02023697

Link

https://clinicaltrials.gov/show/NCT02023697

Keywords

  1. 6/24/19 6/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 24, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Prostatic Neoplasms NCT02023697

Eligibility Prostatic Neoplasms NCT02023697

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed adenocarcinoma of the prostate
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
castration-resistant disease defined as:
Description

Hormone refractory prostate cancer

Data type

boolean

Alias
UMLS CUI [1]
C1328504
serum testosterone level: ≤ 50 ng/dl (1.7 nmol/l)
Description

Serum testosterone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428413
bilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing-hormone-releasing hormone (lhrh) agonist or antagonist, or polyestradiol phosphate
Description

Male Castration | Maintenance Androgen suppression | Luteinizing Hormone-releasing Hormone Agonist | Luteinizing hormone releasing hormone antagonist product | polyestradiol phosphate

Data type

boolean

Alias
UMLS CUI [1]
C0007347
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C1515985
UMLS CUI [3]
C1518041
UMLS CUI [4]
C1276926
UMLS CUI [5]
C0071554
serum psa (prostate specific antigen) progression defined as 2 subsequent increases in psa over a previous reference value (a minimum of 2 ng/ml [μg/l]) or
Description

Raised prostate specific antigen Quantity | Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0201544
radiographic evidence of disease progression in bone (according to prostate cancer clinical trials working group 2 [pcwg2] criteria) with or without psa progression
Description

Disease Progression Bone Radiography | Raised prostate specific antigen | Raised prostate specific antigen Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0262950
UMLS CUI [1,3]
C0034571
UMLS CUI [2]
C0178415
UMLS CUI [3,1]
C0178415
UMLS CUI [3,2]
C0332197
eastern cooperative oncology group performance status (ecog ps) 0 to 2. in case of ecog ps 2, the ps has to be due to metastatic prostate cancer to the bone.
Description

ECOG performance status | Relationship Prostate cancer metastatic to bone

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C4076671
two or more skeletal metastases (≥ 2 hot spots) on bone scintigraphy within 8 weeks of randomization
Description

Neoplasm Metastasis Skeletal Quantity | Hot spot Quantity Bone scintigraphy

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0521324
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C3829661
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C3889015
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of visceral metastasis, or visceral metastases
Description

Neoplasm Metastasis Visceral

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442045
lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter
Description

Lymphadenopathy | Lymph nodes Diameter Short axis

Data type

boolean

Alias
UMLS CUI [1]
C0497156
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0522488
central nervous system (cns) metastases
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
treatment with cytotoxic chemotherapy for prostate cancer within the previous 4 weeks prior to randomization, or planned treatment with cytotoxic chemotherapy agents for prostate cancer during the treatment period or follow-up
Description

Cytotoxic Chemotherapy Prostate carcinoma | Cytotoxic Chemotherapy Planned Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0677881
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C0600139
chronic conditions associated with non-malignant abnormal bone growth (e.g. confirmed paget's disease of bone)
Description

Chronic condition Associated with Abnormal bone growth | Osteitis Deformans

Data type

boolean

Alias
UMLS CUI [1,1]
C4315615
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0005941
UMLS CUI [2]
C0029401
prior treatment with radium-223 dichloride
Description

Radium-223 dichloride

Data type

boolean

Alias
UMLS CUI [1]
C3541342
prior systemic radiotherapy and hemibody external radiotherapy
Description

Therapeutic radiology procedure Systemic | Teleradiotherapy procedure Hemibody

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0419095
UMLS CUI [2,2]
C3846139

Similar models

Eligibility Prostatic Neoplasms NCT02023697

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically or cytologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Hormone refractory prostate cancer
Item
castration-resistant disease defined as:
boolean
C1328504 (UMLS CUI [1])
Serum testosterone measurement
Item
serum testosterone level: ≤ 50 ng/dl (1.7 nmol/l)
boolean
C0428413 (UMLS CUI [1])
Male Castration | Maintenance Androgen suppression | Luteinizing Hormone-releasing Hormone Agonist | Luteinizing hormone releasing hormone antagonist product | polyestradiol phosphate
Item
bilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing-hormone-releasing hormone (lhrh) agonist or antagonist, or polyestradiol phosphate
boolean
C0007347 (UMLS CUI [1])
C0024501 (UMLS CUI [2,1])
C1515985 (UMLS CUI [2,2])
C1518041 (UMLS CUI [3])
C1276926 (UMLS CUI [4])
C0071554 (UMLS CUI [5])
Raised prostate specific antigen Quantity | Prostate specific antigen measurement
Item
serum psa (prostate specific antigen) progression defined as 2 subsequent increases in psa over a previous reference value (a minimum of 2 ng/ml [μg/l]) or
boolean
C0178415 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2])
Disease Progression Bone Radiography | Raised prostate specific antigen | Raised prostate specific antigen Absent
Item
radiographic evidence of disease progression in bone (according to prostate cancer clinical trials working group 2 [pcwg2] criteria) with or without psa progression
boolean
C0242656 (UMLS CUI [1,1])
C0262950 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C0178415 (UMLS CUI [2])
C0178415 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
ECOG performance status | Relationship Prostate cancer metastatic to bone
Item
eastern cooperative oncology group performance status (ecog ps) 0 to 2. in case of ecog ps 2, the ps has to be due to metastatic prostate cancer to the bone.
boolean
C1520224 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C4076671 (UMLS CUI [2,2])
Neoplasm Metastasis Skeletal Quantity | Hot spot Quantity Bone scintigraphy
Item
two or more skeletal metastases (≥ 2 hot spots) on bone scintigraphy within 8 weeks of randomization
boolean
C0027627 (UMLS CUI [1,1])
C0521324 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3829661 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C3889015 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis Visceral
Item
history of visceral metastasis, or visceral metastases
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
Lymphadenopathy | Lymph nodes Diameter Short axis
Item
lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter
boolean
C0497156 (UMLS CUI [1])
C0024204 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0522488 (UMLS CUI [2,3])
CNS metastases
Item
central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
Cytotoxic Chemotherapy Prostate carcinoma | Cytotoxic Chemotherapy Planned Prostate carcinoma
Item
treatment with cytotoxic chemotherapy for prostate cancer within the previous 4 weeks prior to randomization, or planned treatment with cytotoxic chemotherapy agents for prostate cancer during the treatment period or follow-up
boolean
C0677881 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0677881 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
Chronic condition Associated with Abnormal bone growth | Osteitis Deformans
Item
chronic conditions associated with non-malignant abnormal bone growth (e.g. confirmed paget's disease of bone)
boolean
C4315615 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0005941 (UMLS CUI [1,3])
C0029401 (UMLS CUI [2])
Radium-223 dichloride
Item
prior treatment with radium-223 dichloride
boolean
C3541342 (UMLS CUI [1])
Therapeutic radiology procedure Systemic | Teleradiotherapy procedure Hemibody
Item
prior systemic radiotherapy and hemibody external radiotherapy
boolean
C1522449 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0419095 (UMLS CUI [2,1])
C3846139 (UMLS CUI [2,2])

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