EUCTR2022-000082-41-ES进行中（未招募）1 期
Impact of pitavastatin use in prostate cancer patients treated with new generation androgen therapy: multicenter clinical trial
Fundación para la Investigación en Urología0 个研究点目标入组 150 人开始时间: 2022年1月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Patients with a histological diagnosis of prostate cancer, who are in one of the clinical stages listed in the inclusion criteria.
- •listed in the inclusion criteria
- •Patients with hormone-sensitive metastatic prostate cancer (HSPCm), who have not received previous line
- •a.1. Patients with hormone-sensitive metastatic prostate cancer (HSPC), who have not received previous superantiandrogens or chemotherapy.
- •a.2. Patients with metastatic castration-resistant prostate cancer (mCRPC), who have not received previous
- •a.2. Patients with metastatic castration-resistant prostate cancer (mCRPC), who have not received previous superantiandrogens or chemotherapy.
- •The criteria defining castration-resistant prostate cancer are:
- •- Three consecutive PSA elevations, separated by at least one week, with two 50% increments
- •above nadir and provided that this increase results in a PSA greater than 2 ng/ml.
- •- Testosterone levels below 50 ng/dl or 1.7 nmol/l.
- •- Progression of bone lesions = 2 on bone scan or progression of soft tissue lesions according to the RECIST criteria.
- •RECIST criteriaa.
- •3. Non-metastatic castration-resistant prostate cancer (CRPCnm) and high-risk prostate cancer patients
- •(PSA doubling time < 6 months).
- •Patients with PCa will be treated with one of these 4 active drugs for their disease: a.4.
- •-Abiraterone
- •-Enzalutamide
- •-Apalutamide
- •-Darolutamide
- •a.5 Drug to be studied (dependent variable): pitavastatin 2 mg.
- •It should be taken into account that enzalutamide is a potent inducer of cytochrome CYP3A4 and may interact with
- •statins. Differences in hepatic metabolism of statins are of great importance, as they are the main cause of the different interactions between statins and statins.
- •the main cause of the different interactions of these drugs. Thus, atorvastatin, lovastatin and simvastatin are metabolised by isoform 3.
- •metabolised by the 3A4 isoform of cytochrome P450 (CYP3A4), and some drugs can substantially increase the plasma levels of these statins.
- •plasma levels of these statins and, as a consequence, increase the risk of myopathies. Similarly, there are
- •enzyme inducers that will decrease their pharmacological effect (1-3) , such as enzalutamide. Therefore, the
- •statin chosen for the study is pitavastatin since its concentration according to in vitro and in vivo data indicates that it is not
- •is metabolised by the 3A4 isoform of cytochrome P450 in a clinically significant amount, making it the statin with the fewest interactions.
- •statin with the fewest interactions. On the other hand, due to its lipophilic structure it has a wide
- •bioavailability, and can be found in significant concentrations in prostate cells (4)
- •1.Franco D, Henao Y, Monsalve M, et al. Hypolipidemic agents drug interactions: approach to establish and assess its clinical significance.
- •its clinical significance. Structured review. Farm Hosp. 2013 Nov-Dec;37(6):539-57.
- •2. Ríos González E, Martínez-Piñeiro L. Enzalutamide in castration resistant prostate cancer. Arch Esp Urol. 2018
- •Sep;71(8):664-675.
- •Narayanan R, Hoffmann M, Kumar G, et al. Application of a Fit for Purpose PBPK Model to Investigate the CYP3A4 Induction Potential of CYP3A4.
- •CYP3A4 Induction Potential of Enzalutamide. Drug Metab Lett. 2016;10(3):172-179.
- •4. Ahmad H, Cheng-Lai A. Pitavastatin: a new HMG-CoA reductase inhibitor for the treatment of
- •hypercholesterolemia. Cardiol Rev. 2010 Sep-Oct;18(5):264-7.
- •Are the trial subjects under 18? no
排除标准
- •Patients with hyperlipidaemia at the time of diagnosis whether or not under pharmacological treatment; b.2.
- •b.2. Patients with transaminase levels twice the normal value.
- •b.3. Patients in whom information on the variables under study is not available.
- •b.4. Patients who refuse to take part in the study or do not sign the informed consent form.
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