A study of Neoadjuvant Hormone therapy in patient with Advanced Prostate Cancer Undergoing Radical Prostatectomy.

Exclusion Criteria

• 1. Women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods.
• 2. Diagnosis or history of:
• a. Acute metabolic diabetic complications such as ketoacidosis or hyperglycemic hyperosmolar state
• b. Diabetes insipidus.
• 3. Requirement for insulin therapy. Symptoms of poorly controlled diabetes, including but not limited to, marked polyuria and polydipsia with >10% weight loss during the 3 months before enrollment.
• 4. Triglycerides (fasting) > 9.3 mmol/L (> 800 mg/dL).
• 5. Patients with clinically apparent hepatobiliary disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency. ALT or AST > 3x upper limit of normal (ULN), or serum total bilirubin (TB) >34.2 μmol/L (>2 mg/dL).
• 6. Patiens with following renal disease history or renal disease related features:
• a. History of unstable or rapidly progressing renal disease;
• b. Patients with moderate /severe renal impairment or end-stage renal disease (eGFR< 60 mL/min/1.73 m2)
• c. Urinary albumin: creatinine ratio >1800 mg/g;
• d. Serum creatinine (Cr) ≥133 μmol/L (≥1.50 mg/dL) for male subjects; Serum Cr≥124
• μmol/L (≥1.40 mg/dL) for female subjects;
• e. Conditions of congenital renal glycosuria.
• 7. Severe uncontrolled hypertension defined as SBP ≥180 mmHg and/or BP ≥110 mmHg;Patients with SBP < 95mmHg.
• 8. Any of the following cardiovascular diseases within 6 months of the enrollment visit:
• a. Myocardial infarction;
• b. Cardiac surgery or revascularization (coronary artery bypass graft/percutaneous transluminal coronary angioplasty);
• c. Unstable angina;
• d. Congestive heart failure New York Heart Association Class III or IV;
• e. Transient ischemic attack or significant cerebrovascular disease.
• 9. History of gastrointestinal disease or surgery including Roemheld Syndrome, severe hernia, intestinal obstruction, intestinal ulcer, gastroenterostomy, enterectomy, bariatric surgery or lap-band procedure.
• 10. Malignancy within 5 years of the enrollment visit (with the exception of treated basal cell or treated squamous cell carcinoma).
• 11. Known immunocompromised status, including but not limited to, individuals who had undergone organ transplantation or acquired immunodeficiency syndrome (AIDS).
• 12. Any subject who, in the judgment of the investigator, was at risk for dehydration or volume depletion that might affect the interpretation of efficacy or safety data.
• 13. History of bone fracture secondary to diagnosed severe osteoporosis.
• 14. Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases as judged by the Investigator.
• 15. Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for >4 weeks within 3 months before enrollment visit.
• 16. Administration of sibutramine, phentermine, orlistat, rimonabant, benzphetamine, diethylpropion, methamphetamine, or phendimetrazine within 30 days of enrollment visit.
• 17. Any subject who was currently abusing alcohol or other drugs or had done so within the last 6 months
• 18. Donation of blood or blood products, blood transfusion, or participation in a clinical study requiring withdrawal of >400 mL of blood during the 6 weeks before the enrollment visit
• 19. History of hypersensitivity reaction to dapagliflozin or acarbose. Allergies or contraindication to the contents of dapagliflozin tablets or acarbose tablests.
• 20. Previous participation in a clinical trial with dapagliflozin.
• 21. Administration of any other investigational drug within 30 days of planned enrollment to this study, or within 5 half-life periods of other investigational drugs.
• 22. Subject is, in the judgment of the Investigator, unlikely to comply with the protocol or has any severe concurrent medical or psychological condition that may affect the
• interpretation of efficacy or safety data.