ID

43851

Description

Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00500110

Link

https://clinicaltrials.gov/show/NCT00500110

Keywords

  1. 12/1/16 12/1/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT00500110

Eligibility Prostate Cancer NCT00500110

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with adenocarcinoma of the prostate that in the opinion of the surgeon is resectable. ductal adenocarcinoma of the prostate is included.
Description

Adenocarcinoma of prostate Resectable | Ductal adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C1514888
UMLS CUI [2]
C0349672
all patients must be regarded as low anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy.
Description

Anesthesia Low Risk Radical prostatectomy | Radical prostatectomy agreement | Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0002903
UMLS CUI [1,2]
C3538919
UMLS CUI [1,3]
C0194810
UMLS CUI [2,1]
C0194810
UMLS CUI [2,2]
C0680240
UMLS CUI [3]
C0600558
all patients must have at least one of the following high-risk features: clinical or pathological t3 disease, or ct2c or psa>20ng/ml or gleason 8-10 adenocarcinoma or clinical t2b and psa>10ng/ml and gleason 7 adenocarcinoma. the 1992 ajcc staging system will be followed.
Description

High risk factors | AJCC tumor staging | Prostate specific antigen measurement | Gleason score | Adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1830377
UMLS CUI [2]
C0441915
UMLS CUI [3]
C0201544
UMLS CUI [4]
C3203027
UMLS CUI [5]
C0001418
prior hormonal therapy up to 2 months is permitted; no concurrent ketoconazole is permitted.
Description

Hormone Therapy | Ketoconazole

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0022625
patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,500/mm3 and platelet count of >/= 100,000/mm3; adequate hepatic function defined with a total bilirubin of </= 1.5 mg/dl and aspartate aminotransferase (ast or sgot)/alanine aminotransferase (alt or sgpt) </= 2 times the upper limits of normal; adequate renal function defined as serum creatinine clearance >/= 40 cc/min (measured or calculated).
Description

Bone Marrow function | Absolute neutrophil count Peripheral blood | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Bilirubin Calculated

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2,1]
C0948762
UMLS CUI [2,2]
C0229664
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0232741
UMLS CUI [5]
C1278039
UMLS CUI [6,1]
C0005437
UMLS CUI [6,2]
C0444686
patients must sign a written informed consent form prior to treatment. all patients must have a surgical and medical oncology consult prior to signing informed consent.
Description

Informed Consent | Surgical Oncology Consultation | Medical oncology Consultation

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C1515090
UMLS CUI [2,2]
C0009818
UMLS CUI [3,1]
C0025098
UMLS CUI [3,2]
C0009818
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with 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
patients with clinical or radiological evidence of metastatic disease
Description

Neoplasm Metastasis Evidence Clinical | Neoplasm Metastasis Evidence Radiologic

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C3887511
UMLS CUI [2,3]
C0205483
prior chemotherapy or experimental agents
Description

Chemotherapy | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0013230
patients with severe intercurrent infection.
Description

INTERCURRENT INFECTION Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0240021
UMLS CUI [1,2]
C0205082
patients with the new york heart association (nyha) class iii/iv congestive heart failure, unstable angina or myocardial infarction (mi) in the last 6 months.
Description

Congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
contraindications to corticosteroids.
Description

Medical contraindication Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0001617
uncontrolled severe hypertension, uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease or human immunodeficiency virus (hiv) infection.
Description

Uncontrolled hypertension Severe | Diabetic - poor control | Lung disease Oxygen Dependent | Chronic liver disease | HIV Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0421258
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C0030054
UMLS CUI [3,3]
C0851827
UMLS CUI [4]
C0341439
UMLS CUI [5]
C0019693
second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years.
Description

Malignant Neoplasms second | Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205436
UMLS CUI [2]
C0699893
overt psychosis, mental disability or otherwise incompetent to give informed consent or history of non-compliance.
Description

Psychotic Disorder Informed Consent Unable | Mental handicap Informed Consent Unable | Informed Consent incompetent | Compliance behavior Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0033975
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1306341
UMLS CUI [2,2]
C0021430
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0231190
UMLS CUI [4,1]
C1321605
UMLS CUI [4,2]
C0558080

Similar models

Eligibility Prostate Cancer NCT00500110

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate Resectable | Ductal adenocarcinoma of prostate
Item
patients with adenocarcinoma of the prostate that in the opinion of the surgeon is resectable. ductal adenocarcinoma of the prostate is included.
boolean
C0007112 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C0349672 (UMLS CUI [2])
Anesthesia Low Risk Radical prostatectomy | Radical prostatectomy agreement | Neoadjuvant Therapy
Item
all patients must be regarded as low anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy.
boolean
C0002903 (UMLS CUI [1,1])
C3538919 (UMLS CUI [1,2])
C0194810 (UMLS CUI [1,3])
C0194810 (UMLS CUI [2,1])
C0680240 (UMLS CUI [2,2])
C0600558 (UMLS CUI [3])
High risk factors | AJCC tumor staging | Prostate specific antigen measurement | Gleason score | Adenocarcinoma
Item
all patients must have at least one of the following high-risk features: clinical or pathological t3 disease, or ct2c or psa>20ng/ml or gleason 8-10 adenocarcinoma or clinical t2b and psa>10ng/ml and gleason 7 adenocarcinoma. the 1992 ajcc staging system will be followed.
boolean
C1830377 (UMLS CUI [1])
C0441915 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
C3203027 (UMLS CUI [4])
C0001418 (UMLS CUI [5])
Hormone Therapy | Ketoconazole
Item
prior hormonal therapy up to 2 months is permitted; no concurrent ketoconazole is permitted.
boolean
C0279025 (UMLS CUI [1])
C0022625 (UMLS CUI [2])
Bone Marrow function | Absolute neutrophil count Peripheral blood | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Bilirubin Calculated
Item
patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,500/mm3 and platelet count of >/= 100,000/mm3; adequate hepatic function defined with a total bilirubin of </= 1.5 mg/dl and aspartate aminotransferase (ast or sgot)/alanine aminotransferase (alt or sgpt) </= 2 times the upper limits of normal; adequate renal function defined as serum creatinine clearance >/= 40 cc/min (measured or calculated).
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2,1])
C0229664 (UMLS CUI [2,2])
C0032181 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0005437 (UMLS CUI [6,1])
C0444686 (UMLS CUI [6,2])
Informed Consent | Surgical Oncology Consultation | Medical oncology Consultation
Item
patients must sign a written informed consent form prior to treatment. all patients must have a surgical and medical oncology consult prior to signing informed consent.
boolean
C0021430 (UMLS CUI [1])
C1515090 (UMLS CUI [2,1])
C0009818 (UMLS CUI [2,2])
C0025098 (UMLS CUI [3,1])
C0009818 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Small cell carcinoma of prostate | Sarcomatoid carcinoma of prostate
Item
patients with small cell or sarcomatoid prostate cancers are not eligible.
boolean
C1300585 (UMLS CUI [1])
C1335519 (UMLS CUI [2])
Neoplasm Metastasis Evidence Clinical | Neoplasm Metastasis Evidence Radiologic
Item
patients with clinical or radiological evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0205483 (UMLS CUI [2,3])
Chemotherapy | Investigational New Drugs
Item
prior chemotherapy or experimental agents
boolean
C0392920 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
INTERCURRENT INFECTION Severe
Item
patients with severe intercurrent infection.
boolean
C0240021 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction
Item
patients with the new york heart association (nyha) class iii/iv congestive heart failure, unstable angina or myocardial infarction (mi) in the last 6 months.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
Medical contraindication Adrenal Cortex Hormones
Item
contraindications to corticosteroids.
boolean
C1301624 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
Uncontrolled hypertension Severe | Diabetic - poor control | Lung disease Oxygen Dependent | Chronic liver disease | HIV Infection
Item
uncontrolled severe hypertension, uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease or human immunodeficiency virus (hiv) infection.
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0421258 (UMLS CUI [2])
C0024115 (UMLS CUI [3,1])
C0030054 (UMLS CUI [3,2])
C0851827 (UMLS CUI [3,3])
C0341439 (UMLS CUI [4])
C0019693 (UMLS CUI [5])
Malignant Neoplasms second | Skin carcinoma
Item
second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years.
boolean
C0006826 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
C0699893 (UMLS CUI [2])
Psychotic Disorder Informed Consent Unable | Mental handicap Informed Consent Unable | Informed Consent incompetent | Compliance behavior Unwilling
Item
overt psychosis, mental disability or otherwise incompetent to give informed consent or history of non-compliance.
boolean
C0033975 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1306341 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3,1])
C0231190 (UMLS CUI [3,2])
C1321605 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])

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