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])
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])