Age | Informed Consent
Item
1. age 18 or older and willing and able to provide signed informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Adenocarcinoma of prostate | Tumor Length Core biopsy
Item
2. histologically confirmed adenocarcinoma of the prostate , with a minimum maximal tumour length of greater than 6mm on core biopsy
boolean
C0007112 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C1444754 (UMLS CUI [2,2])
C1318309 (UMLS CUI [2,3])
Prior Therapy Absent Prostate carcinoma | Operative Surgical Procedures Absent | Hormone Therapy Absent | Therapeutic radiology procedure Absent | Cold Therapy Absent
Item
3. no previous treatment for prostate cancer (including surgery, any hormone therapy, radiotherapy and cryotherapy)
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0010412 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Biopsy of prostate | Material Biological Marker Assessment
Item
4. prostate biopsy within 8 weeks from screening which contains sufficient material for baseline molecular marker assessment at guy's and st thomas' nhs foundation trust..
boolean
C0194804 (UMLS CUI [1])
C0520510 (UMLS CUI [2,1])
C0005516 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
Radical prostatectomy Scheduled
Item
5. radical prostatectomy is the scheduled treatment of choice
boolean
C0194810 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
ECOG performance status
Item
6. eastern cooperative oncology group (ecog) performance status less than or equal to 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
7. adequate organ function, defined as follows:
boolean
C0678852 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobin >10.0g/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count >1.5x109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count >100x109/l
boolean
C0032181 (UMLS CUI [1])
Renal function | Estimated Glomerular Filtration Rate Cockcroft-Gault formula
Item
renal function, egfr >60ml/min (calculated by cockcroft gault)
boolean
C0232804 (UMLS CUI [1])
C3811844 (UMLS CUI [2,1])
C2924627 (UMLS CUI [2,2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast and/or alt <2.5 x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Serum total bilirubin measurement
Item
total bilirubin <1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Able to swallow Oral medication | Protocol Compliance
Item
8. able to swallow the drug and comply with study requirements.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Metformin
Item
1. patients with a current or historical diagnosis of type one or two diabetes and/or have ever received metformin
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
Hypersensitivity Metformin Component | Hypersensitivity Placebo Oral Tablet Component
Item
2. patients with hypersensitivity to any of the components of metformin or placebo tablet
boolean
C0020517 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1249327 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Condition Associated with Lactic Acidosis | Shock | Pulmonary Insufficiency | Alcoholic Intoxication, Chronic | Condition Associated with Hypoxemia
Item
3. history of or conditions associated with lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), and conditions associated with hypoxaemia
boolean
C0348080 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0001125 (UMLS CUI [1,3])
C0036974 (UMLS CUI [2])
C0034088 (UMLS CUI [3])
C0001973 (UMLS CUI [4])
C0348080 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0700292 (UMLS CUI [5,3])
Chronic liver disease | Severe cardiovascular impairment | Heart failure | Myocardial Infarction | Peripheral Vascular Disease Severe | Renal Insufficiency | Estimated Glomerular Filtration Rate Cockcroft-Gault formula
Item
4. patients with chronic liver disease, severe cardiovascular impairment, cardiac failure, recent myocardial infarction, severe peripheral vascular disease or renal impairment (egfr <60ml/min as measured by cockcroft gault)
boolean
C0341439 (UMLS CUI [1])
C2080705 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0085096 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C1565489 (UMLS CUI [6])
C3811844 (UMLS CUI [7,1])
C2924627 (UMLS CUI [7,2])
Severe disorder | Febrile infection | Pancreatitis | Trauma | Dehydration | Reduced diet
Item
5. patients with acute severe disorders, for example infections with fever, pancreatitis, trauma, dehydration or reduced diet (<1000kcal or 4200kj per day)
boolean
C1836348 (UMLS CUI [1])
C0948233 (UMLS CUI [2])
C0030305 (UMLS CUI [3])
C3714660 (UMLS CUI [4])
C0011175 (UMLS CUI [5])
C0012167 (UMLS CUI [6])
Cancer Other Requirement Systemic therapy
Item
6. other active malignancy over the last five years that has required systemic therapy, excluding:
boolean
C1707251 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
Exception Adjuvant therapy Curative
Item
adjuvant therapy in the curative setting
boolean
C1705847 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])
Exception Skin carcinoma
Item
non-melanoma skin cancer
boolean
C1705847 (UMLS CUI [1,1])
C0699893 (UMLS CUI [1,2])
Exception Transitional Cell Carcinoma Superficial TNM clinical staging
Item
superficial transitional cell carcinoma (cis-t1)
boolean
C1705847 (UMLS CUI [1,1])
C0007138 (UMLS CUI [1,2])
C0205124 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
7. current enrolment in an investigational drug or device study or participation in such a study within 30 days of signing consent.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Male fertility Barrier Contraception Unwilling | Male fertility Condom use Unwilling
Item
8. any subjects who is able to father a child and does not agree to use barrier protection, in the form of a condom ,for the duration of the trial and for 16 weeks after the last study drug administration.
boolean
C1955321 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C1955321 (UMLS CUI [2,1])
C0679782 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])