2023-508072-11-00招募中3 期
A Phase III trial of acetylsalicylic acid and atorvastatin in patients with castrate-resistant prostate cancer (PEACE 4)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,210
- 试验地点
- 39
- 主要终点
- Overall survival (OS). OS will be calculated from the date of randomization to the date of death (or the last follow-up date in case of censored data).
研究概览
简要总结
The primary objective is to evaluate the benefit of acetylsalicylic acid and atorvastatin on overall survival (OS) (main endpoint)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate and no curative local therapy considered possible
- •Information delivered to patient and informed consent form signed by the patient.
- •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). Patients may have received up to 6 weeks of one of these first-line life-prolonging systemic treatments for their CRPC before they are included in the trial. 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)
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)
- •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
- •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).
结局指标
主要结局
Overall survival (OS). OS will be calculated from the date of randomization to the date of death (or the last follow-up date in case of censored data).
Overall survival (OS). OS will be calculated from the date of randomization to the date of death (or the last follow-up date in case of censored data).
次要结局
- Prostate cancer specific survival (events including only deaths due to prostate cancer)
- Progression-Free Survival (including PSA progression by PCWG3 criteria (recommended) or if not by investigator’s assessment)
- Radiographic Progression-Free Survival (progression defined by PCWG3 criteria)
- Time to next anticancer treatment
- Safety (NCI-CTC V5.0 criteria). G1 to G5 acetylsalicylic acid and statin-related known AEs and all the other events only G3-5.
- G1 to G5 AEs considered related to acetylsalicylic acid and/or statin and about all others AEs only G3-5 have to be collected.
- Cardio-vascular morbidity: cardiovascular hospitalization (e.g. stroke, myocardial infarction) and cardio-vascular mortality or any G3/4 cardiovascular AE
- Changes from baseline of BMI (BMI=weight (kg)/height (m)2), body weight and waist measure under treatment
- Translational research: Metabolic parameters (including baseline lipid profile and change in levels of lipids under treatment)
- Translational research: Low levels of Vitamin D at baseline
- Translational research: LNR (Lymphocyte to Neutrophil Ratio) and CRP
- Translational research: Lipid signature
研究者
Regulatory Affairs Officer
Scientific
Institut Gustave Roussy
研究点 (39)
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