Age
Item
1. age ≥18 years at the time of signing the informed consent form.
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
2. histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
boolean
C0007112 (UMLS CUI [1])
Docetaxel failed | Intolerance to Docetaxel | Abiraterone failed | Enzalutamide failed
Item
3. failing or not tolerating docetaxel therapy or for other reasons not suitable for such therapy and failing subsequent therapy with abiraterone and/or enzalutamide.
boolean
C0246415 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
C0754011 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C3496793 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
Neoplasm Metastasis Bone scan | Bone lesion | Neoplasm Metastasis Imaging
Item
4. evidence of metastatic disease from bone scan (bone lesions) or other imaging modality.
boolean
C0027627 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C0238792 (UMLS CUI [2])
C0027627 (UMLS CUI [3,1])
C0079595 (UMLS CUI [3,2])
Raised prostate specific antigen Determination Quantity
Item
5. evidence of psa progression in two consecutive determinations at minimum 1 week interval.
boolean
C0178415 (UMLS CUI [1,1])
C0521095 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Castration Levels of Testosterone Serum testosterone measurement
Item
6. castrate level of serum testosterone ≤1.7 nmol/l
boolean
C4289828 (UMLS CUI [1,1])
C0428413 (UMLS CUI [1,2])
ECOG performance status
Item
7. performance status ecog 0-2
boolean
C1520224 (UMLS CUI [1])
Laboratory Requirement | Hematology | Neutrophil count | Hemoglobin measurement | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum | Electrolytes | Serum sodium level normal | Serum potassium normal | Serum calcium normal | Calcium/albumin Normal | Serum phosphate level normal | Serum magnesium normal
Item
8. laboratory requirements: haematology: neutrophils ≥ 1.5 x 109/l hemoglobin ≥ 90 g/l platelets ≥ 100 x 109/l hepatic function: total s-bilirubin ≤ 1.5 times the upper limit of normal (uln) ast (sgot) / alt (sgpt) ≤ 2.5 times uln renal function: s-creatinine ≤ 1.5 times the upper limit of normal (uln) electrolytes: s-sodium, s-potassium, s-calcium (s-albumin corrected), s-phosphate, s-magnesium, all within normal ranges.
boolean
C0022877 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0200627 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0232741 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C0201899 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
C0232804 (UMLS CUI [10])
C0201976 (UMLS CUI [11])
C0013832 (UMLS CUI [12])
C0580480 (UMLS CUI [13])
C0858161 (UMLS CUI [14])
C0858094 (UMLS CUI [15])
C0553061 (UMLS CUI [16,1])
C0205307 (UMLS CUI [16,2])
C0580488 (UMLS CUI [17])
C0858145 (UMLS CUI [18])
Malignant Neoplasms Absent | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
9. no evidence (≤ 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).
boolean
C0006826 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Protocol Compliance
Item
10. able to adhere to the study visit schedule and other protocol requirements.
boolean
C0525058 (UMLS CUI [1])
Life Expectancy
Item
11. life expectancy ≥6 months
boolean
C0023671 (UMLS CUI [1])
Antineoplastic Agents | Cancer treatment | Exception LHRH Agonist Dose Stable | Exception LHRH antagonist Dose Stable | Exception Polyestradiol phosphate Dose Stable | Exception Bicalutamide Dose Stable | Washout Period Bicalutamide | Washout Period Flutamide | Washout Period Abiraterone | Washout Period Enzalutamide
Item
1. concurrent use of other anti-cancer agents or treatments, with the following exception: a stable dose of lhrh agonist/antagonist or polyestradiol phosphate bicalutamide. washout period bicalutamide 6 weeks; after flutamide 4 weeks; abiraterone / enzalutamide 6 weeks.
boolean
C0003392 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1518041 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1276926 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0205360 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0071554 (UMLS CUI [5,2])
C0178602 (UMLS CUI [5,3])
C0205360 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0285590 (UMLS CUI [6,2])
C0178602 (UMLS CUI [6,3])
C0205360 (UMLS CUI [6,4])
C1710661 (UMLS CUI [7,1])
C0285590 (UMLS CUI [7,2])
C1710661 (UMLS CUI [8,1])
C0016384 (UMLS CUI [8,2])
C1710661 (UMLS CUI [9,1])
C0754011 (UMLS CUI [9,2])
C1710661 (UMLS CUI [10,1])
C3496793 (UMLS CUI [10,2])
Chemotherapy | Therapeutic radiology procedure | Major surgery
Item
2. any treatment modalities involving chemotherapy, radiation or major surgery within 4 weeks prior to treatment in this study.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0679637 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs
Item
3. simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Condition Interferes with Interpretation Research data | Laboratory test result abnormal Interferes with Interpretation Research data | Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk
Item
4. any condition, including the presence of laboratory abnormalities, which confounds the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,3])
C0681873 (UMLS CUI [1,4])
C0438215 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0681873 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0438215 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
Plasma Glucose Measurement
Item
5. plasma glucose level ≥7 mmol/l (or >120 mg/dl) at screening.
boolean
C0202042 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
6. known brain metastases.
boolean
C0220650 (UMLS CUI [1])
Dental surgical procedure | Tooth Extraction | Periodontal Disease | Trauma Local | Denture unstable
Item
7. dental surgery (dental extraction), periodontal disease, local trauma including poorly fitting dentures within 6 months prior to the first dose of study drug.
boolean
C0204324 (UMLS CUI [1])
C0040440 (UMLS CUI [2])
C0031090 (UMLS CUI [3])
C1301685 (UMLS CUI [4,1])
C0205276 (UMLS CUI [4,2])
C0457728 (UMLS CUI [5])
Diphosphonates
Item
8. treatment with bisphosphonates within 4 weeks prior to first dose of study medication.
boolean
C0012544 (UMLS CUI [1])