ID

40974

Description

Carbon-11 Acetate and Fluorine F 18 Sodium Fluoride PET as a Biomarker of Treatment Response in Patients With Hormone Resistant Metastatic Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02169063

Link

https://clinicaltrials.gov/show/NCT02169063

Keywords

Versions (1)
  1. 6/7/20 6/7/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 7, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hormone-resistant Prostate Cancer NCT02169063

English

Eligibility Hormone-resistant Prostate Cancer NCT02169063

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients preparing to receive systemic therapy to treat metastatic castration-resistant prostate cancer
Description

Systemic therapy Hormone refractory prostate cancer metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1328504
UMLS CUI [1,3]
C1522484
at the time of enrollment, patients must demonstrate evidence of castration-resistant prostate cancer with a documented castrate level of serum total testosterone (< 50 ng/dl) while on continuous androgen deprivation therapy
Description

Hormone refractory prostate cancer | Castration Levels of Testosterone Total serum testosterone measurement | Antiandrogen therapy

Data type

boolean

Alias
UMLS CUI [1]
C1328504
UMLS CUI [2,1]
C4289828
UMLS CUI [2,2]
C2210797
UMLS CUI [3]
C0279492
be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
be willing and able to comply with scheduled visits and other trial procedures
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
presence of at least one measurable or detectable metastasis as defined by bone scintigraphy, computed tomography (ct) scan appearance (magnetic resonance imaging [mri] if indicated), or plain x-ray appearance
Description

Neoplasm Metastasis Measurable Quantity | Neoplasm Metastasis Detectable Quantity | Bone scintigraphy | CT scan | MRI | Plain x-ray

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C3830527
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C3889015
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0024485
UMLS CUI [6]
C1306645
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any condition that would alter the patient's mental status, prohibiting the basic understanding and/or authorization of informed consent
Description

Condition Changing Mental state | Condition Preventing Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0278060
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
a serious underlying medical condition that would otherwise impair the patient's ability to receive treatment and imaging studies
Description

Primary disorder Impairing Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0277554
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0525058
expected lifespan of 12 weeks or less
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
extremely poor intravenous access, prohibiting the placement of a peripheral iv line for injection of radiotracer
Description

Poor venous access Preventing Radiotracer Injection

Data type

boolean

Alias
UMLS CUI [1,1]
C0577866
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0597354
UMLS CUI [1,4]
C1828121
radiation treatment to bone less than 4 weeks from the first pet scan
Description

Irradiation of bone

Data type

boolean

Alias
UMLS CUI [1]
C2169038
radiopharmaceutical treatment to bone less than 4 weeks from first pet scan
Description

Radiopharmaceutical therapy Bone

Data type

boolean

Alias
UMLS CUI [1,1]
C2094663
UMLS CUI [1,2]
C0262950
treatment with granulocyte-macrophage colony stimulating factor (gm-csf) or granulocyte (g-csf) within 4 weeks prior to first pet scan; patients should avoid treatment with these agents between the baseline and 6-12 treatment week imaging sessions
Description

Granulocyte-Macrophage Colony-Stimulating Factor | Granulocyte Colony-Stimulating Factor

Data type

boolean

Alias
UMLS CUI [1]
C0079460
UMLS CUI [2]
C0079459
inability to lie still for imaging
Description

Lacking Able to lie down Quiet | Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0560841
UMLS CUI [1,3]
C0439654
UMLS CUI [2]
C0011923
weight > 300 pounds (lbs)
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
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Similar models

Eligibility Hormone-resistant Prostate Cancer NCT02169063

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Systemic therapy Hormone refractory prostate cancer metastatic
Item
patients preparing to receive systemic therapy to treat metastatic castration-resistant prostate cancer
boolean
C1515119 (UMLS CUI [1,1])
C1328504 (UMLS CUI [1,2])
C1522484 (UMLS CUI [1,3])
Hormone refractory prostate cancer | Castration Levels of Testosterone Total serum testosterone measurement | Antiandrogen therapy
Item
at the time of enrollment, patients must demonstrate evidence of castration-resistant prostate cancer with a documented castrate level of serum total testosterone (< 50 ng/dl) while on continuous androgen deprivation therapy
boolean
C1328504 (UMLS CUI [1])
C4289828 (UMLS CUI [2,1])
C2210797 (UMLS CUI [2,2])
C0279492 (UMLS CUI [3])
Informed Consent
Item
be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
be willing and able to comply with scheduled visits and other trial procedures
boolean
C0525058 (UMLS CUI [1])
Neoplasm Metastasis Measurable Quantity | Neoplasm Metastasis Detectable Quantity | Bone scintigraphy | CT scan | MRI | Plain x-ray
Item
presence of at least one measurable or detectable metastasis as defined by bone scintigraphy, computed tomography (ct) scan appearance (magnetic resonance imaging [mri] if indicated), or plain x-ray appearance
boolean
C0027627 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C3889015 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C1306645 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Condition Changing Mental state | Condition Preventing Informed Consent
Item
any condition that would alter the patient's mental status, prohibiting the basic understanding and/or authorization of informed consent
boolean
C0348080 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0278060 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Primary disorder Impairing Protocol Compliance
Item
a serious underlying medical condition that would otherwise impair the patient's ability to receive treatment and imaging studies
boolean
C0277554 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Life Expectancy
Item
expected lifespan of 12 weeks or less
boolean
C0023671 (UMLS CUI [1])
Poor venous access Preventing Radiotracer Injection
Item
extremely poor intravenous access, prohibiting the placement of a peripheral iv line for injection of radiotracer
boolean
C0577866 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0597354 (UMLS CUI [1,3])
C1828121 (UMLS CUI [1,4])
Irradiation of bone
Item
radiation treatment to bone less than 4 weeks from the first pet scan
boolean
C2169038 (UMLS CUI [1])
Radiopharmaceutical therapy Bone
Item
radiopharmaceutical treatment to bone less than 4 weeks from first pet scan
boolean
C2094663 (UMLS CUI [1,1])
C0262950 (UMLS CUI [1,2])
Granulocyte-Macrophage Colony-Stimulating Factor | Granulocyte Colony-Stimulating Factor
Item
treatment with granulocyte-macrophage colony stimulating factor (gm-csf) or granulocyte (g-csf) within 4 weeks prior to first pet scan; patients should avoid treatment with these agents between the baseline and 6-12 treatment week imaging sessions
boolean
C0079460 (UMLS CUI [1])
C0079459 (UMLS CUI [2])
Lacking Able to lie down Quiet | Imaging
Item
inability to lie still for imaging
boolean
C0332268 (UMLS CUI [1,1])
C0560841 (UMLS CUI [1,2])
C0439654 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2])
Body Weight
Item
weight > 300 pounds (lbs)
boolean
C0005910 (UMLS CUI [1])
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