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试验摘要
The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.
更多研究详情
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获取更多信息
关于正在招募参与者的 A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study，您是否想了解更多临床试验中心相关信息？请在右侧填写您的信息联系我们，我们将予以回复。
地点
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入选标准- Subject must currently be receiving enzalutamide for prostate cancer in a study sponsored by Astellas or Medivation and, based on the investigator’s assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
- Subject is able to continue on the treatment regimen that the subject was receiving in the prior study. If in the investigator’s assessment, a change is needed to the subject’s regimen (e.g., dose change in Androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.
- Subject is able to swallow enzalutamide capsules and comply with study requirements.
- Subject and female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective and 1 must be a barrier method throughout the study and for 3 months after final enzalutamide administration.
- Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
- Subject agrees not to participate in another interventional study while on treatment.
排除标准- Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from.
- Subject requires treatment with or plans to use either of the following:
- New systemic therapy for subjects cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment.
- Investigational therapy other than enzalutamide.
- Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
- Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.
常见问题
虽然某些临床试验可能侧重于更晚期的癌症，但许多试验对处于不同癌症阶段的患者开放。每项研究都有关于参与资格的规定。例如，只有特定年龄段的患者或患有特定类型肿瘤的患者才能参与。
有时，研究人员希望参与者在临床试验期间继续接受当前治疗。有时，您可能需要暂停当前的治疗。如果研究性治疗无效，您通常可以恢复原有的治疗方案。
在癌症临床试验中，只有当该类癌症尚无其他治疗方法时，才会使用安慰剂。这有助于将研究性治疗与安慰剂进行比较。安慰剂在癌症试验中很少使用，因为通常会采用最佳可用疗法，即所谓的“标准治疗方案”。
您的医生可能并不了解所有可供您参与的临床试验机会。请与您的医生或其他医疗服务提供者讨论您所找到的临床试验信息。他们可以帮助您判断临床试验是否适合您。If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.
