EUCTR2017-004639-35-FR进行中（未招募）1 期
A Phase III trial of acetylsalicylic acid and atorvastatin in patients with castrate-resistant prostate cancer - PEACE-4
Gustave Roussy0 个研究点目标入组 1,210 人开始时间: 2018年8月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,210
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
- •Histologically confirmed adenocarcinoma of the prostate and no curative local therapy considered possible
- •Age = 18 years, life expectancy of at least 6 months
- •CRPC defined as tumor progression (PSA increase on at least 2 separate values separated by at least 1 week or progression on imaging) while on Androgen Deprivation Therapy (orchiectomy, LHRH agonist or –antagonist) with documented serum testosterone levels = 1.7 nmol/L (= 0.50 ng/mL). Ongoing concurrent use of LHRH agonist or antagonist is required if the patient has not been surgically castrated
- •Presence (M1) or absence (M0) of metastases on imaging
- •Performance status 0, 1 or 2
- •No previous use of life- prolonging treatments for CRPC (including abiraterone, enzalutamide, radium-223, docetaxel, cabazitaxel, and sipuleucel-T). The use of these agents together with Androgen Deprivation Therapy (ADT) for castrate-sensitive disease is allowed.
- •Adequate renal function within 30 days prior to registration: calculated creatinine clearance = 50 mL/min, according to the formula of Cockcroft-Gault and adequate liver function with levels of AST and ALT = 3xULN and no signs for cholestasis.
- •Participation in other clinical trials is allowed except for trials with the same primary endpoint, i.e. OS
- •Patient authorized to participate to a clinical trial by specific country regulation (eg patient affiliated to a social security system or beneficiary of the same)
- •Information delivered to patient and informed consent form signed by the patient.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1000
排除标准
- •Previous localised malignancy within 2 years with the exception of localized non-melanoma skin cancer and Ta or Tis bladder cancer (patients with asymptomatic Chronic Lymphoïd Leukemia can be included)
- •Previous metastatic malignancy within 5 years
- •Patient currently taking daily acetylsalicylic acid or a daily statin within the last 6 months
- •Patients with active liver disease (hepatitis B or C, cirrhosis) or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal or cholestasis
- •. Patients with excessive alcohol intake or history of a relevant liver disease
- •Known hypersensitivity or intolerance to acetylsalicylic acid or atorvastatin or hypersensitivity to any of its components
- •Contra-indication to acetylsalicylic acid or atorvastatin according to label, including known high-risk for haemorrhage,
- •History of or active myopathy or significantly elevated (> 5 times ULN) CK levels
- •History of recent stroke or transient ischemic attack (TIA).
- •Any concomitant drugs contraindicated for use with the trial drugs according to the product information (e.g. Fucidic acid, potent inhibitors of CYP3A4 or transport proteins: ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, tripanavir, telaprevir, saquinavir, darunavir, fosamprenavir, boceprivir, gemfibrozil, fenofibrate, etc)
- •Any serious underlying medical condition (by the investigator’s judgement) which could impair the ability of the patient to participate in the trial
- •Patients with hereditary galactose intolerance, Lapp-lactase deficiency or Glucose-Galactose-malabsorption
- •Compliance with trial medical follow-up impossible due to geographic, social or psychological reasons
- •Psychiatric disorder precluding understanding of information about trial related topics, providing informed consent, or interfering with compliance for oral drug intake
研究者
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