ID

36948

Description

A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02499497

Link

https://clinicaltrials.gov/show/NCT02499497

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 Cancer NCT02499497

English

Eligibility Prostate Cancer NCT02499497

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 19 years or older. men with prostate cancer, who have organ-localized disease with very low risk of disease recurrence, as indicated by stage pt2, n0, m0 lesions, combined gleason score of 6 or less with no gleason 4 elements, and preoperative psa<10 ng/ml. the rationale for selecting men with these criteria is that this group of men has <0.5% disease recurrence rate over ten years
Description

Age | Gender | Prostate carcinoma | Disease Organ Localized | Low Risk Very Disease recurrence | Lesion TNM clinical staging | Gleason score | Prostate specific antigen measurement Preoperative | Disease recurrence Percentage Timespan

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0600139
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0178784
UMLS CUI [4,3]
C0392752
UMLS CUI [5,1]
C3538919
UMLS CUI [5,2]
C0442824
UMLS CUI [5,3]
C0679254
UMLS CUI [6,1]
C0221198
UMLS CUI [6,2]
C3258246
UMLS CUI [7]
C3203027
UMLS CUI [8,1]
C0201544
UMLS CUI [8,2]
C0445204
UMLS CUI [9,1]
C0679254
UMLS CUI [9,2]
C0439165
UMLS CUI [9,3]
C0872291
stable and undetectable psa level (psa <0.1 ng/ml using an assay that has a functional sensitivity of 0.1 ng/ml) for at least two years after radical prostatectomy
Description

PSA Level Stable Undetectable | Prostate specific antigen measurement | Status post Radical prostatectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C4086720
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C3827727
UMLS CUI [2]
C0201544
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0194810
serum testosterone, measured by lc-ms/ms, <300 mg/dl and/or free testosterone by equilibrium dialysis <60 pg/ml. self-reported sexual dysfunction (iief score <25 or sexual desire score <7), fatigue (facit-f score >30), or physical dysfunction (self-reported difficulty in walking a 1/4 mile or climbing two flights of stairs, short physical performance battery score 4 to 9).
Description

Testosterone measurement Liquid Chromatography Mass Spectrometry | Free Testosterone Measurement Equilibrium dialysis | Sexual Dysfunction IIEF Questionnaire | Level of Sexual Desire Score | Fatigue FACIT Fatigue Scale | Physical impairment | Difficulty walking Distance Short Physical Performance Battery score | Difficulty with Climbing Several Flights of Stairs Short Physical Performance Battery score

Data type

boolean

Alias
UMLS CUI [1,1]
C0523912
UMLS CUI [1,2]
C0872318
UMLS CUI [2,1]
C0202228
UMLS CUI [2,2]
C1553177
UMLS CUI [3,1]
C0549622
UMLS CUI [3,2]
C3641331
UMLS CUI [4,1]
C4084903
UMLS CUI [4,2]
C0449820
UMLS CUI [5,1]
C0015672
UMLS CUI [5,2]
C3272505
UMLS CUI [6]
C0231171
UMLS CUI [7,1]
C0311394
UMLS CUI [7,2]
C0429886
UMLS CUI [7,3]
C4075289
UMLS CUI [8,1]
C0332218
UMLS CUI [8,2]
C3831080
UMLS CUI [8,3]
C4075289
ability to understand and the willingness to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
men who have undergone radiation therapy alone will be excluded because defining biochemical recurrence can be difficult in these men due to fluctuating psa levels.
Description

Therapeutic radiology procedure Alone | PSA Level Fluctuating

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205171
UMLS CUI [2,1]
C4086720
UMLS CUI [2,2]
C0231241
men receiving androgen deprivation therapy
Description

Antiandrogen therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279492
hemoglobin <10 g/dl or >16.5 g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
severe untreated sleep apnea
Description

Sleep Apnea Severe Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0037315
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332155
uncontrolled heart failure
Description

Heart failure Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205318
myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months
Description

Myocardial Infarction | Acute Coronary Syndrome | Revascularization | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0948089
UMLS CUI [3]
C0581603
UMLS CUI [4]
C0038454
serum creatinine >2.5 mg/dl; alt or ast greater than 3x the institutional upper limit of normal (uln)
Description

Creatinine measurement, serum | Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
hemoglobin a1c >7.5% or diabetes requiring insulin therapy
Description

Hemoglobin A1c measurement | Diabetes Mellitus Requirement Insulin regime

Data type

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0557978
body mass index (bmi) >40 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
major psychiatric disorder, such as schizophrenia, bipolar disorder, or untreated depression
Description

Mental disorder Major | Schizophrenia | Bipolar Disorder | Depressive disorder Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0005586
UMLS CUI [4,1]
C0011581
UMLS CUI [4,2]
C0332155
use of any of the following medications within the past 6 months: testosterone, dhea, estrogens, gnrh analogs, antiandrogens, spironolactone, ketoconazole, rhgh, megestrol acetate, prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks
Description

Testosterone | DHEA | Estrogens | GnRH Analog | Androgen Antagonists | Spironolactone | Ketoconazole | Recombinant Human Growth Hormone | Megestrol Acetate | Prednisone U/day | Glucocorticoids Dose Equivalent

Data type

boolean

Alias
UMLS CUI [1]
C0039601
UMLS CUI [2]
C0011185
UMLS CUI [3]
C0014939
UMLS CUI [4]
C1518041
UMLS CUI [5]
C0002842
UMLS CUI [6]
C0037982
UMLS CUI [7]
C0022625
UMLS CUI [8]
C0384570
UMLS CUI [9]
C0065879
UMLS CUI [10,1]
C0032952
UMLS CUI [10,2]
C0456683
UMLS CUI [11,1]
C0017710
UMLS CUI [11,2]
C0178602
UMLS CUI [11,3]
C0205163
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Similar models

Eligibility Prostate Cancer NCT02499497

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Gender | Prostate carcinoma | Disease Organ Localized | Low Risk Very Disease recurrence | Lesion TNM clinical staging | Gleason score | Prostate specific antigen measurement Preoperative | Disease recurrence Percentage Timespan
Item
age 19 years or older. men with prostate cancer, who have organ-localized disease with very low risk of disease recurrence, as indicated by stage pt2, n0, m0 lesions, combined gleason score of 6 or less with no gleason 4 elements, and preoperative psa<10 ng/ml. the rationale for selecting men with these criteria is that this group of men has <0.5% disease recurrence rate over ten years
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0600139 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0178784 (UMLS CUI [4,2])
C0392752 (UMLS CUI [4,3])
C3538919 (UMLS CUI [5,1])
C0442824 (UMLS CUI [5,2])
C0679254 (UMLS CUI [5,3])
C0221198 (UMLS CUI [6,1])
C3258246 (UMLS CUI [6,2])
C3203027 (UMLS CUI [7])
C0201544 (UMLS CUI [8,1])
C0445204 (UMLS CUI [8,2])
C0679254 (UMLS CUI [9,1])
C0439165 (UMLS CUI [9,2])
C0872291 (UMLS CUI [9,3])
PSA Level Stable Undetectable | Prostate specific antigen measurement | Status post Radical prostatectomy
Item
stable and undetectable psa level (psa <0.1 ng/ml using an assay that has a functional sensitivity of 0.1 ng/ml) for at least two years after radical prostatectomy
boolean
C4086720 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C3827727 (UMLS CUI [1,3])
C0201544 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0194810 (UMLS CUI [3,2])
Testosterone measurement Liquid Chromatography Mass Spectrometry | Free Testosterone Measurement Equilibrium dialysis | Sexual Dysfunction IIEF Questionnaire | Level of Sexual Desire Score | Fatigue FACIT Fatigue Scale | Physical impairment | Difficulty walking Distance Short Physical Performance Battery score | Difficulty with Climbing Several Flights of Stairs Short Physical Performance Battery score
Item
serum testosterone, measured by lc-ms/ms, <300 mg/dl and/or free testosterone by equilibrium dialysis <60 pg/ml. self-reported sexual dysfunction (iief score <25 or sexual desire score <7), fatigue (facit-f score >30), or physical dysfunction (self-reported difficulty in walking a 1/4 mile or climbing two flights of stairs, short physical performance battery score 4 to 9).
boolean
C0523912 (UMLS CUI [1,1])
C0872318 (UMLS CUI [1,2])
C0202228 (UMLS CUI [2,1])
C1553177 (UMLS CUI [2,2])
C0549622 (UMLS CUI [3,1])
C3641331 (UMLS CUI [3,2])
C4084903 (UMLS CUI [4,1])
C0449820 (UMLS CUI [4,2])
C0015672 (UMLS CUI [5,1])
C3272505 (UMLS CUI [5,2])
C0231171 (UMLS CUI [6])
C0311394 (UMLS CUI [7,1])
C0429886 (UMLS CUI [7,2])
C4075289 (UMLS CUI [7,3])
C0332218 (UMLS CUI [8,1])
C3831080 (UMLS CUI [8,2])
C4075289 (UMLS CUI [8,3])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure Alone | PSA Level Fluctuating
Item
men who have undergone radiation therapy alone will be excluded because defining biochemical recurrence can be difficult in these men due to fluctuating psa levels.
boolean
C1522449 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C4086720 (UMLS CUI [2,1])
C0231241 (UMLS CUI [2,2])
Antiandrogen therapy
Item
men receiving androgen deprivation therapy
boolean
C0279492 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin <10 g/dl or >16.5 g/dl
boolean
C0518015 (UMLS CUI [1])
Sleep Apnea Severe Untreated
Item
severe untreated sleep apnea
boolean
C0037315 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
Heart failure Uncontrolled
Item
uncontrolled heart failure
boolean
C0018801 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Myocardial Infarction | Acute Coronary Syndrome | Revascularization | Cerebrovascular accident
Item
myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months
boolean
C0027051 (UMLS CUI [1])
C0948089 (UMLS CUI [2])
C0581603 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
Creatinine measurement, serum | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
serum creatinine >2.5 mg/dl; alt or ast greater than 3x the institutional upper limit of normal (uln)
boolean
C0201976 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Hemoglobin A1c measurement | Diabetes Mellitus Requirement Insulin regime
Item
hemoglobin a1c >7.5% or diabetes requiring insulin therapy
boolean
C0474680 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0557978 (UMLS CUI [2,3])
Body mass index
Item
body mass index (bmi) >40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Mental disorder Major | Schizophrenia | Bipolar Disorder | Depressive disorder Untreated
Item
major psychiatric disorder, such as schizophrenia, bipolar disorder, or untreated depression
boolean
C0004936 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
C0011581 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
Testosterone | DHEA | Estrogens | GnRH Analog | Androgen Antagonists | Spironolactone | Ketoconazole | Recombinant Human Growth Hormone | Megestrol Acetate | Prednisone U/day | Glucocorticoids Dose Equivalent
Item
use of any of the following medications within the past 6 months: testosterone, dhea, estrogens, gnrh analogs, antiandrogens, spironolactone, ketoconazole, rhgh, megestrol acetate, prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks
boolean
C0039601 (UMLS CUI [1])
C0011185 (UMLS CUI [2])
C0014939 (UMLS CUI [3])
C1518041 (UMLS CUI [4])
C0002842 (UMLS CUI [5])
C0037982 (UMLS CUI [6])
C0022625 (UMLS CUI [7])
C0384570 (UMLS CUI [8])
C0065879 (UMLS CUI [9])
C0032952 (UMLS CUI [10,1])
C0456683 (UMLS CUI [10,2])
C0017710 (UMLS CUI [11,1])
C0178602 (UMLS CUI [11,2])
C0205163 (UMLS CUI [11,3])
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