ID

36967

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02023697

Nyckelord

Versioner (1)
  1. 2019-06-24 2019-06-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 juni 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT02023697

Engelsk

Eligibility Prostatic Neoplasms NCT02023697

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Adenocarcinoma of prostate

Datatyp

boolean

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

Hormone refractory prostate cancer

Datatyp

boolean

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

Serum testosterone measurement

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Raised prostate specific antigen Quantity | Prostate specific antigen measurement

Datatyp

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
Beskrivning

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

Datatyp

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.
Beskrivning

ECOG performance status | Relationship Prostate cancer metastatic to bone

Datatyp

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
Beskrivning

Neoplasm Metastasis Skeletal Quantity | Hot spot Quantity Bone scintigraphy

Datatyp

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
Beskrivning

Exclusion Criteria

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

Neoplasm Metastasis Visceral

Datatyp

boolean

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

Lymphadenopathy | Lymph nodes Diameter Short axis

Datatyp

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
Beskrivning

CNS metastases

Datatyp

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
Beskrivning

Cytotoxic Chemotherapy Prostate carcinoma | Cytotoxic Chemotherapy Planned Prostate carcinoma

Datatyp

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)
Beskrivning

Chronic condition Associated with Abnormal bone growth | Osteitis Deformans

Datatyp

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
Beskrivning

Radium-223 dichloride

Datatyp

boolean

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

Therapeutic radiology procedure Systemic | Teleradiotherapy procedure Hemibody

Datatyp

boolean

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

Eligibility Prostatic Neoplasms NCT02023697

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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