ISRCTN16951765已完成2 期
SPECTRE - Combined suppression of cholesterol bioavailability and androgen deprivation therapy to treat castration resistant prostate cancer: an interventional study
HS Greater Glasgow and Clyde0 个研究点目标入组 14 人开始时间: 2016年2月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •Current participant inclusion criteria as of 16/07/2018:
- •1. Proven adenocarcinoma of the prostate, defined as:
- •1.1. Histological or cytological evidence of prostate cancer,
- •1.2. PSA > 100 at time of diagnosis and presence of more than 4 bone metastases
- •2. Disease progression despite on-going castration therapy (either using LHRH analogue or prior surgical orchiectomy (with or without abiraterone or enzalutamide) as judged by rising serial PSA measurements. This will be based on a series of at least 3 readings each taken at least 7 days apart. The 3rd reading must be = 2 ng/ml. In the event where an intermediate reading is lower than a previous reading, then the patient will still be eligible (i.e. the 3 readings do not need to be consecutive). In patients who have received prior bicalutamide, flutamide or nilutamide, PSA progression must be proven after withdrawal of this drug.
- •3. Castrate levels of serum testosterone
- •4. Ongoing castration therapy (either LHRH analogue or prior orchiectomy, with or without abiraterone or enzalutamide). Please note, although the continuation of abiraterone or enzalutamide may be permitted, this must firstly be discussed with the chief investigator for approval, prior to study entry.
- •5. No therapy with statins or other cholesterol-lowering drug during a 28 day period prior to initiation of trial medication.
- •6. Male aged 18 or over
- •7. Life expectancy greater than 6 months
- •8. Adequate hepatic, bone marrow, coagulation and renal function as defined by the following criteria:
- •8.1. Haemoglobin = 9.0 g/dL
- •8.2. Platelets = 100 x 109L
- •8.3. Creatinine
- •8.4. Hepatic function: total bilirubin = 2 x ULN; ALT and AST = 3 x ULN
- •8.5. Creatine kinase = 5 x ULN
- •8.6. Prothrombin time = 1.5 x ULN; APTT = 1.5 x ULN
- •9. Willingness to comply with scheduled visits, medication plans and laboratory tests and other trial procedures
- •10. Ability to swallow oral medications
- •11. Willing to undergo two biopsies for research purposes with a lesion (either primary or secondary) amenable to biopsy
- •Previous participant inclusion criteria:
- •1. Histologically proven adenocarcinoma of the prostate (patients may or may not have evidence of metastatic disease)
- •2. Disease progression despite on-going castration therapy (either using LHRH analogue or prior surgical orchiectomy) as judged by rising serial PSA measurements: This will be based on a series of at least 3 readings each taken at least 7 days apart. The 3rd reading must be =2 ng/ml. In the event where an intermediate reading is lower than a previous reading, then the patient will still be eligible (i.e. the 3 readings do not need to be consecutive). In patients who have received prior bicalutamide, flutamide or nilutamide, PSA progression must be proven after withdrawal of this drug
- •3. Castrate levels of serum testosterone (<1.7 nmol/l)
- •4. Ongoing castration therapy (either LHRH analogue or prior orchiectomy)
- •5. No therapy with statins or other cholesterol-lowering drug during a 2-month period prior to initiation of trial medication
- •6. Male aged 18 or over
- •7. Life expectancy greater than 6 months
- •8. Adequate hepatic, bone marrow coagulation and renal function as defined by the following criteria:
- •8.1.Haemoglobin > 9.0 g/dL
- •8.2.Platelets > 100 x 109L
- •8.3.Creatinine <2 x ULN
- •8.4.Hepatic function: total bilirubin = 2 x ULN; ALT and AST = 3 x ULN
- •8.5.Creatine kinase ,= 5 x ULN
- •8.6.Fasting glucose = 5.6 mmol/L
- •8.7.Prothrombin time = 1.5 x ULN; APTT = 1.5 x ULN
- •8.8. Platelets = 100
排除标准
- •Current participant exclusion criteria as of 16/07/2018:
- •1. Uncontrolled hypertension (defined as systolic = 170 mmHg and/or diastolic = 100 mmHg, despite optimal therapy)
- •2. The requirement for strong opiates to control cancer related pain (codeine and tramadol are permitted)
- •3. NYHA class III or IV heart failure or Childs-Pugh liver failure class B or worse
- •4. Patients with symptomatic or radiographic disease progression (Note: Imaging studies will not be conducted specifically to meet this criterion but only if clinically indicated in accordance with standard of care)
- •5. Other severe or uncontrolled systemic disease or evidence of any other significant disorder or lab finding that makes it undesirable for the patient to participate in the trial
- •6. History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol, or any psychological, familial, sociological or geographical consideration potentially hampering compliance with the trial protocol and follow up schedule.
- •7. Administration of any investigational drug within 28 days of receiving the first dose of trial medication
- •8. Major surgery within 28 days prior to trial registration
- •9. Active condition which affects drug absorption (e.g. prior gastrectomy or active peptic ulcer disease)
- •10. Planned change in systemic therapy for 6 weeks after study medication initiation
- •11. Planned requirement for radiotherapy or surgery for 6 weeks after study initiation
- •12. Prior hypersensitivity to atorvastatin or its constituents
- •13. Requirement for on-going anti-coagulant therapy (including heparins and warfarin)
- •Previous participant exclusion criteria:
- •1. Uncontrolled hypertension (defined as systolic = 170mmHg and/or diastolic = 100 mmHg despite optimal therapy)
- •2. The requirement for strong opiates to control cancer related pain; codeine and tramadol are
- •3. NYHA class III or IV heart failure or Childs-Pugh liver failure class B or worse
- •4. Patients with symptomatic or radiographic disease progression (Note: Imaging studies will not be conducted specifically to meet this criterion but only if clinically indicated in accordance with standard of care)
- •5. Other severe or uncontrolled systemic disease or evidence of any other significant disorder or lab finding that makes it undesirable for the patient to participate in the trial
- •6. History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol, or any psychological, familial, sociological or geographical consideration potentially hampering compliance with the trial protocol and follow up schedule. Administration of any investigational drug within 28 days of receiving the first dose of trial treatment
- •7. Major surgery within 28 days prior to trial entry
- •8. Active condition which affects drug absorption (e.g. prior gastrectomy or active peptic ulcer disease)
- •9. Planned change in systemic therapy for 6 weeks after study initiation
- •10. Planned requirement for radiotherapy or surgery for 6 weeks after study initiation
- •11. Prior hypersensitivity to atorvastatin or its constituents
- •12. Requirement for on-going anti-coagulant therapy (including heparins and warfarin)
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