ID

36884

Beschrijving

PROSTAC: Multicentre Biomarker Study in CRPC Treated With Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT02362620

Link

https://clinicaltrials.gov/show/NCT02362620

Trefwoorden

Versies (1)
  1. 18-06-19 18-06-19 -
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See clinicaltrials.gov

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18 juni 2019

DOI

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Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02362620

Engels

Eligibility Prostate Cancer NCT02362620

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
2. eighteen years of age or older.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. general health status acceptable and compatible with active treatment: ecog ≤0-2.
Beschrijving

Health Status Acceptable | Health Status Compatible with Therapeutic procedure | ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C1879533
UMLS CUI [2,1]
C0018759
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0087111
UMLS CUI [3]
C1520224
4. histological confirmation of prostate cancer diagnosis.
Beschrijving

Prostate carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0600139
5. prior resistance to biochemical castration with an lhrh agonist (or surgical castration through bilateral orchiectomy) and progression to an anti-androgen drug (e.g. bicalutamide, nilutamide or cyproterone acetate).
Beschrijving

Resistant to Chemical male castration | Resistant to LHRH Agonist | Resistant to Male Castration | Androgen Antagonists | bicalutamide | nilutamide | Cyproterone Acetate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332325
UMLS CUI [1,2]
C0455189
UMLS CUI [2,1]
C0332325
UMLS CUI [2,2]
C1518041
UMLS CUI [3,1]
C0332325
UMLS CUI [3,2]
C0007347
UMLS CUI [4]
C0002842
UMLS CUI [5]
C0285590
UMLS CUI [6]
C0068771
UMLS CUI [7]
C0056855
6. biochemical progression upon prior treatment in agreement with psawg2 criteria, confirmed by a second psa test.
Beschrijving

Prior Therapy | Disease Progression Biochemical

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0205474
7. castrate levels of testosterone in peripheral blood: testosterone <0.5 ng/ml.
Beschrijving

Castration Levels of Testosterone Peripheral blood | Testosterone measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C4289828
UMLS CUI [1,2]
C0229664
UMLS CUI [2]
C0523912
8. candidates for standard treatment with:
Beschrijving

Patients Appropriate Standard therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C2936643
1. docetaxel (75 mg/m2 every three weeks) plus prednisone (5 mg/12 h). or
Beschrijving

Docetaxel Dose Frequency | Prednisone Dose /12h

Datatype

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439603
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456695
2. cabazitaxel (20 or 25 mg/m2 every three weeks) plus prednisone (5 mg/12 h).
Beschrijving

Cabazitaxel Dose Frequency | Prednisone Dose /12h

Datatype

boolean

Alias
UMLS CUI [1,1]
C2830183
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439603
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456695
9. availability of anatomopathological tumour material (e.g. a paraffin block of the prostatectomy or initial biopsy of the metastasis).
Beschrijving

Availability of Paraffin Embedded Tissue Prostatectomy | Paraffin Embedded Tissue Biopsy Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C1519524
UMLS CUI [1,3]
C0033573
UMLS CUI [2,1]
C1519524
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C0027627
10. acceptable hematological, hepatic and renal functions and without contraindications for the administration of docetaxel or cabaziatxel in agreement with its respective summary of products characteristics.
Beschrijving

Hematologic function | Liver function | Renal function | Medical contraindication Absent Docetaxel | Medical contraindication Absent Cabazitaxel

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0246415
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C2830183
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free, as well as subjects with a history of skin cancers (of non-melanoma type) or excised in situ carcinomas.
Beschrijving

Malignant Neoplasms | Exception Malignant Neoplasm Localized | Exception Malignant Neoplasm Free of | Exception Skin carcinoma | Exception Carcinoma in Situ Resected

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C0392752
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0006826
UMLS CUI [3,3]
C0332296
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0699893
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007099
UMLS CUI [5,3]
C1521996
2. medical histories, be they psychiatric or of any other character, which, according to the judgement of the investigator, might interfere with the subject's granting of informed consent or the safe execution of the procedures required in the study.
Beschrijving

Medical History Interferes with Informed Consent | Medical History Interferes with Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
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Similar models

Eligibility Prostate Cancer NCT02362620

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. provision of informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. eighteen years of age or older.
boolean
C0001779 (UMLS CUI [1])
Health Status Acceptable | Health Status Compatible with Therapeutic procedure | ECOG performance status
Item
3. general health status acceptable and compatible with active treatment: ecog ≤0-2.
boolean
C0018759 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0018759 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1520224 (UMLS CUI [3])
Prostate carcinoma
Item
4. histological confirmation of prostate cancer diagnosis.
boolean
C0600139 (UMLS CUI [1])
Resistant to Chemical male castration | Resistant to LHRH Agonist | Resistant to Male Castration | Androgen Antagonists | bicalutamide | nilutamide | Cyproterone Acetate
Item
5. prior resistance to biochemical castration with an lhrh agonist (or surgical castration through bilateral orchiectomy) and progression to an anti-androgen drug (e.g. bicalutamide, nilutamide or cyproterone acetate).
boolean
C0332325 (UMLS CUI [1,1])
C0455189 (UMLS CUI [1,2])
C0332325 (UMLS CUI [2,1])
C1518041 (UMLS CUI [2,2])
C0332325 (UMLS CUI [3,1])
C0007347 (UMLS CUI [3,2])
C0002842 (UMLS CUI [4])
C0285590 (UMLS CUI [5])
C0068771 (UMLS CUI [6])
C0056855 (UMLS CUI [7])
Prior Therapy | Disease Progression Biochemical
Item
6. biochemical progression upon prior treatment in agreement with psawg2 criteria, confirmed by a second psa test.
boolean
C1514463 (UMLS CUI [1])
C0242656 (UMLS CUI [2,1])
C0205474 (UMLS CUI [2,2])
Castration Levels of Testosterone Peripheral blood | Testosterone measurement
Item
7. castrate levels of testosterone in peripheral blood: testosterone <0.5 ng/ml.
boolean
C4289828 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
C0523912 (UMLS CUI [2])
Patients Appropriate Standard therapy
Item
8. candidates for standard treatment with:
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C2936643 (UMLS CUI [1,3])
Docetaxel Dose Frequency | Prednisone Dose /12h
Item
1. docetaxel (75 mg/m2 every three weeks) plus prednisone (5 mg/12 h). or
boolean
C0246415 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0032952 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456695 (UMLS CUI [2,3])
Cabazitaxel Dose Frequency | Prednisone Dose /12h
Item
2. cabazitaxel (20 or 25 mg/m2 every three weeks) plus prednisone (5 mg/12 h).
boolean
C2830183 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0032952 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456695 (UMLS CUI [2,3])
Availability of Paraffin Embedded Tissue Prostatectomy | Paraffin Embedded Tissue Biopsy Neoplasm Metastasis
Item
9. availability of anatomopathological tumour material (e.g. a paraffin block of the prostatectomy or initial biopsy of the metastasis).
boolean
C0470187 (UMLS CUI [1,1])
C1519524 (UMLS CUI [1,2])
C0033573 (UMLS CUI [1,3])
C1519524 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
Hematologic function | Liver function | Renal function | Medical contraindication Absent Docetaxel | Medical contraindication Absent Cabazitaxel
Item
10. acceptable hematological, hepatic and renal functions and without contraindications for the administration of docetaxel or cabaziatxel in agreement with its respective summary of products characteristics.
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0246415 (UMLS CUI [4,3])
C1301624 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C2830183 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Exception Malignant Neoplasm Localized | Exception Malignant Neoplasm Free of | Exception Skin carcinoma | Exception Carcinoma in Situ Resected
Item
1. previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free, as well as subjects with a history of skin cancers (of non-melanoma type) or excised in situ carcinomas.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0392752 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0699893 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0007099 (UMLS CUI [5,2])
C1521996 (UMLS CUI [5,3])
Medical History Interferes with Informed Consent | Medical History Interferes with Protocol Compliance
Item
2. medical histories, be they psychiatric or of any other character, which, according to the judgement of the investigator, might interfere with the subject's granting of informed consent or the safe execution of the procedures required in the study.
boolean
C0262926 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
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