Advanced Prostate Cancer Clinical Trial
Official title:
A Multi-centre, Single-arm, Prospective Study to Assess Efficacy and Safety of Neoadjuvant Hormone Therapy Using Zoladex (Goserelin) and Casodex (Bicalutamide) in Patients With Advanced Prostate Cancer Undergoing Radical Prostatectomy.
Verified date | December 2022 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is A Multi-centre, Single-arm, Prospective, Interventional Study to Assess Efficacy and Safety of Neoadjuvant Hormone Therapy using Zoladex (Goserelin) and Casodex (Bicalutamide) in Patients with Advanced Prostate Cancer Undergoing Radical Prostatectomy, to assess the efficacy by resectability rate of neoadjuvant hormone therapy (NHT) in subjects with advanced prostate cancer.
Status | Terminated |
Enrollment | 9 |
Est. completion date | November 9, 2022 |
Est. primary completion date | November 9, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Diagnosed within the past 12 months with T2DM according to 1999 WHO criteria 2. Men and women aged at least 18 years at screening. 3. Either not received oral anti-diabetic drugs or had been on short-term (1 month) treatment that had been discontinued 3 months before enrolment. 4. HbA1c = 7.5% and = 10.5% at screening and HbA1c = 7.0% and = 10.5% at pre-randomization visit. 5. FPG = 13.3 mmol/L (= 240 mg/dL) . 6. BMI=18.5 kg/m2 and = 45.0 kg/m2 . 7. C-peptide =0.33nmol/L(=1.0 ng/mL). 8. Able and willing to provide written informed consent and to comply with the study. 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: 1. Acute metabolic diabetic complications such as ketoacidosis or hyperglycemic hyperosmolar state 2. 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: 1. History of unstable or rapidly progressing renal disease; 2. Patients with moderate /severe renal impairment or end-stage renal disease (eGFR< 60 mL/min/1.73 m2) 3. Urinary albumin: creatinine ratio >1800 mg/g; 4. 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; 5. 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: 1. Myocardial infarction; 2. Cardiac surgery or revascularization (coronary artery bypass graft/percutaneous transluminal coronary angioplasty); 3. Unstable angina; 4. Congestive heart failure New York Heart Association Class III or IV; 5. 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. |
Country | Name | City | State |
---|---|---|---|
China | Research Site | Beijing | |
China | Research Site | Changsha | |
China | Research Site | Changsha | |
China | Research Site | Chengdu | |
China | Research Site | Guangzhou | |
China | Research Site | Guangzhou | |
China | Research Site | Hangzhou | |
China | Research Site | Hangzhou | |
China | Research Site | Hefei | |
China | Research Site | Shanghai | |
China | Research Site | Shenyang | |
China | Research Site | Shijiazhuang | |
China | Research Site | Urumqi | |
China | Research Site | Xi'an | |
China | Research Site | Zhengzhou |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
China,
1. Montironi R, Schulman CC. Pathological changes in prostate lesions after androgen manipulation. J Clin Pathol 1998; 51:5-12. 2. Witjes WP, Schulman CC, Debruyne FM. Preliminary results of a prospective randomized study comparing radical prostatectomy v
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resectability rate for primary tumour (the resectability will be assessed by central review using a digital rectal examination and confirmed by CT or MRI) | To assess the efficacy by resectability rate of neoadjuvant hormone therapy (NHT) in subjects with advanced prostate cancer | at 24 week | |
Secondary | Radical prostatectomy rate | Which will be derived using the number of patient who will conduct the radical prostatectomy at 24 week. | From baseline to 24 week | |
Secondary | The mean PSA by the end of NHT | which will be derived using the value of mean PSA by the end of NHT | From baseline to 24 week | |
Secondary | Percentage of positive surgical margin for primary tumour | Which will be derived using the number of positive surgical margin at 24 week | From baseline to 24 week | |
Secondary | Incidence of seminal vesicle invasion | Which will be derived using the value of incidence of seminal vesicle invasion at 24 week | From baseline to 24 week. | |
Secondary | Percentage of pathological downstaging | Which will be derived using the number of pathological downstaging at 24 week. | From baseline to 24 week | |
Secondary | surgical-related variables at 12 weeks, potent rates in erectile function at 12 weeks after surgery | Which will be derived using the value of observe surgical-related variables and complications at week 36 | From 24 week to 36 week | |
Secondary | PFS | Which will be derived using the number of PFS at the end of study | From baseline to the end of study | |
Secondary | AEs/SAEs | To evaluate the safety of NHT using goserelin and bicalutamide | From baseline to 28 week | |
Secondary | PSA change from baseline | Which will be derived using the value of PSA at the baseline. | From baseline to 24 week | |
Secondary | Involvement of bilateral pelvic lymph nodes | Which will be derived using the value of involvement of bilateral pelvic lymph nodes at 24 week. | From baseline to 24 week | |
Secondary | OS | Which will be derived using the number of OS at the end of study. | From baseline to the end of study |
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