ID

42853

Description

Testosterone in Castration-Resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00577980

Link

https://clinicaltrials.gov/show/NCT00577980

Keywords

Versions (2)
  1. 8/25/17 8/25/17 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00577980

English

Eligibility Prostate Cancer NCT00577980

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a history of histologically or cytologically confirmed adenocarcinoma of the prostate.
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
patients must have had a history of a response to medical or surgical castration therapy for prostate cancer with a serum psa nadir of </= 0.2 ng/ml and must not have had any known subsequent rise in serum psa level of any magnitude above this nadir within the first 24 months of hormonal therapy. nadir psa value following hormonal therapy in combination with non-hormonal therapy such as radical prostatectomy, radiation therapy or chemotherapy do not count towards eligibility.
Description

Male Castration Prostate carcinoma | Disease Response | PSA Nadir

Data type

boolean

Alias
UMLS CUI [1,1]
C0007347
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C1704632
UMLS CUI [3,1]
C0201544
UMLS CUI [3,2]
C1708760
patients must have current evidence of progressive castration-resistant disease that is asymptomatic. progressive disease is defined by a) radiological evidence of progression: any increase of > 25% in the products of diameters or 30% in maximum diameter of any measurable lesion; or appearance of an unequivocally new lesion or b) two consecutive rises in serum psa of any magnitude measured at least 2 weeks apart, to a level above 2 ng/ml.
Description

Castration-Resistant Prostatic Neoplasm Progressive Asymptomatic | Progressive Disease Diagnostic radiologic examination | Measurable Lesion Diameter Increase | New Lesion Identification | Serum PSA Increased Measurement Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C3658267
UMLS CUI [1,2]
C0205329
UMLS CUI [1,3]
C0231221
UMLS CUI [2,1]
C1335499
UMLS CUI [2,2]
C0043299
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0442805
UMLS CUI [4]
C2986548
UMLS CUI [5,1]
C1883014
UMLS CUI [5,2]
C0242485
UMLS CUI [5,3]
C1265611
patients must have a minimum serum psa level of 1 ng/ml.
Description

PSA level Minimum

Data type

boolean

Alias
UMLS CUI [1,1]
C0428540
UMLS CUI [1,2]
C1524031
patients may have palpable disease or radiological evidence of metastatic disease but without the following high-risk features: lymphangitic lung disease on chest x-ray or ct scan; bilateral hydronephrosis related to prostate cancer, palpable disease in the prostate, known brain metastases or suspicion of impending spinal cord or nerve root compression.
Description

Palpable disease | Neoplasm Metastasis Diagnostic radiologic examination | Feature High risk Absent | Lymphangitic metastasis to lung Chest X-ray | Lymphangitic metastasis to lung Chest CT | Bilateral hydronephrosis Relationship Prostate carcinoma | Palpable disease Prostate | Metastatic malignant neoplasm to brain | Suspicion Compression of spinal cord Impending | Suspicion Compression of spinal nerve root Impending

Data type

boolean

Alias
UMLS CUI [1]
C0522499
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0043299
UMLS CUI [3,1]
C2348519
UMLS CUI [3,2]
C0332167
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C2062926
UMLS CUI [4,2]
C0039985
UMLS CUI [5,1]
C2062926
UMLS CUI [5,2]
C0202823
UMLS CUI [6,1]
C0521622
UMLS CUI [6,2]
C0439849
UMLS CUI [6,3]
C0600139
UMLS CUI [7,1]
C0522499
UMLS CUI [7,2]
C0033572
UMLS CUI [8]
C0220650
UMLS CUI [9,1]
C0242114
UMLS CUI [9,2]
C0037926
UMLS CUI [9,3]
C0332190
UMLS CUI [10,1]
C0242114
UMLS CUI [10,2]
C0576717
UMLS CUI [10,3]
C0332190
patients must have a documented castrate level of testosterone (</= 50ng/ml). for patients who are medically castrated, luteinizing hormone releasing hormone analog will continue. the purpose is to simplify and harmonize exogenous testosterone therapeutics.
Description

Testosterone Castration Level

Data type

boolean

Alias
UMLS CUI [1,1]
C0039601
UMLS CUI [1,2]
C0007347
UMLS CUI [1,3]
C0441889
patients on anti-androgens should be discontinued from such therapy for at least 4 weeks (for bicalutamide for at least 6 weeks), prior to initiation of testosterone therapy and must have had documented progression of disease as in #3.
Description

Antiandrogen therapy To be stopped | Bicalutamide To be stopped | Testosterone Therapeutic procedure Initiation | Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C1272691
UMLS CUI [2,1]
C0285590
UMLS CUI [2,2]
C1272691
UMLS CUI [3,1]
C0039601
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C1704686
UMLS CUI [4]
C0242656
patients must satisfy the following laboratory criteria: serum total bilirubin < 2 *
Description

Laboratory Criteria Fulfill | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
UMLS CUI [2]
C1278039
institutional upper limit of normal (uln) and serum aspartate aminotransferase (ast or sgot) and alanine aminotransferase (alt or sgpt) </= 2.5 * institutional uln.
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
the eastern cooperative oncology group (ecog) performance status 0-3.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
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
small cell or sarcomatoid prostate cancers are not eligible.
Description

Small cell carcinoma of prostate | Sarcomatoid Carcinoma of Prostate

Data type

boolean

Alias
UMLS CUI [1]
C1300585
UMLS CUI [2]
C1335519
no prior chemotherapy for crpc.
Description

Chemotherapy Castration-resistant prostate cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1328504
patients may not be receiving any other investigational agents or hormonal therapy besides that specified in the study.
Description

Investigational New Drugs | Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0279025
uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
Description

Angina Pectoris Uncontrolled | Ventricular arrhythmia Uncontrolled Severe | Ischemia Electrocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0085612
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0022116
UMLS CUI [3,2]
C1623258
uncontrolled intercurrent illness including, but not limited to, ongoing or active infections defined as requiring iv antibiotics on day 1 of treatment or psychiatric illness/social situations that would limit compliance with study requirements.
Description

Comorbidity Uncontrolled | Communicable Diseases Requirement Antibiotics Intravenous | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003232
UMLS CUI [2,4]
C1522726
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C0439801
UMLS CUI [4,1]
C0748872
UMLS CUI [4,2]
C0525058
UMLS CUI [4,3]
C0439801
unwilling or unable because of comorbid conditions to tolerate intramuscular injections of testosterone every 2 weeks.
Description

Intramuscular testosterone Receive Unwilling | Intramuscular testosterone allergy Due to Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0359088
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0571684
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0009488
overt psychosis, mental disability or otherwise incompetent to give informed consent or history of non-compliance.
Description

Psychotic Disorders | Mental handicap | Incompetence Informed Consent | Patient Non-Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C1306341
UMLS CUI [3,1]
C0231189
UMLS CUI [3,2]
C0021430
UMLS CUI [4]
C0376405
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Similar models

Eligibility Prostate Cancer NCT00577980

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
patients must have a history of histologically or cytologically confirmed adenocarcinoma of the prostate.
boolean
C0007112 (UMLS CUI [1])
Male Castration Prostate carcinoma | Disease Response | PSA Nadir
Item
patients must have had a history of a response to medical or surgical castration therapy for prostate cancer with a serum psa nadir of </= 0.2 ng/ml and must not have had any known subsequent rise in serum psa level of any magnitude above this nadir within the first 24 months of hormonal therapy. nadir psa value following hormonal therapy in combination with non-hormonal therapy such as radical prostatectomy, radiation therapy or chemotherapy do not count towards eligibility.
boolean
C0007347 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2])
C0201544 (UMLS CUI [3,1])
C1708760 (UMLS CUI [3,2])
Castration-Resistant Prostatic Neoplasm Progressive Asymptomatic | Progressive Disease Diagnostic radiologic examination | Measurable Lesion Diameter Increase | New Lesion Identification | Serum PSA Increased Measurement Quantity
Item
patients must have current evidence of progressive castration-resistant disease that is asymptomatic. progressive disease is defined by a) radiological evidence of progression: any increase of > 25% in the products of diameters or 30% in maximum diameter of any measurable lesion; or appearance of an unequivocally new lesion or b) two consecutive rises in serum psa of any magnitude measured at least 2 weeks apart, to a level above 2 ng/ml.
boolean
C3658267 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0231221 (UMLS CUI [1,3])
C1335499 (UMLS CUI [2,1])
C0043299 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0442805 (UMLS CUI [3,3])
C2986548 (UMLS CUI [4])
C1883014 (UMLS CUI [5,1])
C0242485 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
PSA level Minimum
Item
patients must have a minimum serum psa level of 1 ng/ml.
boolean
C0428540 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Palpable disease | Neoplasm Metastasis Diagnostic radiologic examination | Feature High risk Absent | Lymphangitic metastasis to lung Chest X-ray | Lymphangitic metastasis to lung Chest CT | Bilateral hydronephrosis Relationship Prostate carcinoma | Palpable disease Prostate | Metastatic malignant neoplasm to brain | Suspicion Compression of spinal cord Impending | Suspicion Compression of spinal nerve root Impending
Item
patients may have palpable disease or radiological evidence of metastatic disease but without the following high-risk features: lymphangitic lung disease on chest x-ray or ct scan; bilateral hydronephrosis related to prostate cancer, palpable disease in the prostate, known brain metastases or suspicion of impending spinal cord or nerve root compression.
boolean
C0522499 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0043299 (UMLS CUI [2,2])
C2348519 (UMLS CUI [3,1])
C0332167 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C2062926 (UMLS CUI [4,1])
C0039985 (UMLS CUI [4,2])
C2062926 (UMLS CUI [5,1])
C0202823 (UMLS CUI [5,2])
C0521622 (UMLS CUI [6,1])
C0439849 (UMLS CUI [6,2])
C0600139 (UMLS CUI [6,3])
C0522499 (UMLS CUI [7,1])
C0033572 (UMLS CUI [7,2])
C0220650 (UMLS CUI [8])
C0242114 (UMLS CUI [9,1])
C0037926 (UMLS CUI [9,2])
C0332190 (UMLS CUI [9,3])
C0242114 (UMLS CUI [10,1])
C0576717 (UMLS CUI [10,2])
C0332190 (UMLS CUI [10,3])
Testosterone Castration Level
Item
patients must have a documented castrate level of testosterone (</= 50ng/ml). for patients who are medically castrated, luteinizing hormone releasing hormone analog will continue. the purpose is to simplify and harmonize exogenous testosterone therapeutics.
boolean
C0039601 (UMLS CUI [1,1])
C0007347 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
Antiandrogen therapy To be stopped | Bicalutamide To be stopped | Testosterone Therapeutic procedure Initiation | Disease Progression
Item
patients on anti-androgens should be discontinued from such therapy for at least 4 weeks (for bicalutamide for at least 6 weeks), prior to initiation of testosterone therapy and must have had documented progression of disease as in #3.
boolean
C0279492 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0285590 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0039601 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C1704686 (UMLS CUI [3,3])
C0242656 (UMLS CUI [4])
Laboratory Criteria Fulfill | Serum total bilirubin measurement
Item
patients must satisfy the following laboratory criteria: serum total bilirubin < 2 *
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C1278039 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
institutional upper limit of normal (uln) and serum aspartate aminotransferase (ast or sgot) and alanine aminotransferase (alt or sgpt) </= 2.5 * institutional uln.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
ECOG performance status
Item
the eastern cooperative oncology group (ecog) performance status 0-3.
boolean
C1520224 (UMLS CUI [1])
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)
Small cell carcinoma of prostate | Sarcomatoid Carcinoma of Prostate
Item
small cell or sarcomatoid prostate cancers are not eligible.
boolean
C1300585 (UMLS CUI [1])
C1335519 (UMLS CUI [2])
Chemotherapy Castration-resistant prostate cancer
Item
no prior chemotherapy for crpc.
boolean
C0392920 (UMLS CUI [1,1])
C1328504 (UMLS CUI [1,2])
Investigational New Drugs | Hormone Therapy
Item
patients may not be receiving any other investigational agents or hormonal therapy besides that specified in the study.
boolean
C0013230 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Angina Pectoris Uncontrolled | Ventricular arrhythmia Uncontrolled Severe | Ischemia Electrocardiography
Item
uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
boolean
C0002962 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0085612 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0022116 (UMLS CUI [3,1])
C1623258 (UMLS CUI [3,2])
Comorbidity Uncontrolled | Communicable Diseases Requirement Antibiotics Intravenous | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infections defined as requiring iv antibiotics on day 1 of treatment or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003232 (UMLS CUI [2,3])
C1522726 (UMLS CUI [2,4])
C0004936 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0748872 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
Intramuscular testosterone Receive Unwilling | Intramuscular testosterone allergy Due to Comorbidity
Item
unwilling or unable because of comorbid conditions to tolerate intramuscular injections of testosterone every 2 weeks.
boolean
C0359088 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0571684 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0009488 (UMLS CUI [2,3])
Psychotic Disorders | Mental handicap | Incompetence Informed Consent | Patient Non-Compliance
Item
overt psychosis, mental disability or otherwise incompetent to give informed consent or history of non-compliance.
boolean
C0033975 (UMLS CUI [1])
C1306341 (UMLS CUI [2])
C0231189 (UMLS CUI [3,1])
C0021430 (UMLS CUI [3,2])
C0376405 (UMLS CUI [4])
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