Observational Study of Metastatic Prostate Cancer Subjects Receiving Docetaxel Therapy for Evaluation of Docetaxel Plasma Levels Using the MyDocetaxel Assay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 20
- 主要终点
- Docetaxel treatment related toxicities
研究概览
简要总结
In this observational study, blood samples for pharmacokinetic (PK) testing will be collected from subjects with metastatic prostate cancer during their treatment with docetaxel. Plasma levels of docetaxel will be determined, and the subjects docetaxel exposure levels, determined as an area under the curve (AUC), will be retrospectively correlated with reports of toxicity, tumor response, quality of life, time to disease progression and overall survival to provide guidance on what the appropriate target range for docetaxel exposure should be for metastatic prostate cancer subjects receiving docetaxel therapy for their disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
- •Male subjects 18 years of age or older.
- •About to start a new line of treatment with docetaxel (75 mg/m2) in combination with prednisone.
- •All subjects must be informed of the investigational nature of this study and be willing to provide written informed consent in accordance with Institutional guidelines and good clinical practices (GCP) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study prior to the beginning of specific study procedures.
- •Prior surgical castration or concurrent use of an agent for chemical castration with a serum testosterone level < 50 ng/dL.
- •Subjects with hormone naïve metastatic prostate cancer, must have high-volume disease, defined as extra-nodal visceral disease or bone metastases with at least 4 bone lesions (one being outside of the vertebral column or pelvis).
- •Subjects with hormone naïve high-volume metastatic prostate adenocarcinoma must have been on androgen deprivation therapy (including luteinizing hormone-releasing hormone (LHRH) agonist therapy, LHRH antagonist therapy, or surgical castration) for less than 120 days prior to starting docetaxel therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •For subjects with castrate resistant prostate cancer (CRPC), at least four weeks elapsed between withdrawal of anti-androgens (Bicalutamide, Flutamide or Nilutamide) and initiation of docetaxel therapy.
- •For subjects with CRPC, at least four weeks elapsed between last administration of Abiraterone (Zytiga®) or Enzalutamide (Xtandi®) and initiation of docetaxel therapy.
- •At least four weeks elapsed between prior surgery or prior radiotherapy and initiation of docetaxel therapy.
- •Radiograph-documented evidence of soft tissue or bony metastatic disease.
- •Must have adequate hematologic, hepatic and renal function as defined below:
- •Hematologic (minimal values): Absolute neutrophil count ≥ 1,500/mm3; Hemoglobin ≥ 10.0 g/dl; Platelet count ≥ 75,000/mm3
- •Hepatic Function: Total Bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); asparate transaminase (AST) and alanine transaminase (ALT) < 2 x institutional ULN
- •Suitable venous access and healthy enough (as determined by the treating physician) to provide whole blood sample.
排除标准
- •Any condition / concomitant disease not allowing chemotherapy with docetaxel, prednisone or required premedication for the treatment regimen.
- •Serious concurrent disorders (active infection requiring intravenous antibiotics, unstable angina, uncompensated congestive heart failure (CHF), or hepatic failure) that, in the opinion of the investigator, would prevent the use of docetaxel and/or compromise the subject's ability to provide whole blood samples for participation in the study.
- •Concurrent use of any non-FDA approved (i.e. investigational or experimental) anticancer agent(s) or within four (4) weeks of enrolling on the study.
- •Pre-existing neuropathy ≥ grade 2 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version
- •Individuals with known seropositivity for human immunodeficiency virus (HIV), hepatitis C virus, hepatitis B surface antigen, or syphilis.
- •Unwilling or unable to follow protocol requirements or to provide informed consent.
研究组 & 干预措施
hormone naïve
Subjects with hormone naïve metastatic prostate cancer that have high-volume disease and have been on androgen deprivation therapy for less than 120 days prior to starting docetaxel therapy.
干预措施: docetaxel (Drug)
hormone naïve
Subjects with hormone naïve metastatic prostate cancer that have high-volume disease and have been on androgen deprivation therapy for less than 120 days prior to starting docetaxel therapy.
干预措施: Blood draws (Other)
castrate resistant
Subjects with castrate resistant prostate cancer (CRPC) [defined as having evidence of prostate specific antigen (PSA) progression despite androgen deprivation therapy] that have had at least four weeks elapse between the withdrawal of anti-androgens (Bicalutamide, Flutamide or Nilutamide) and the initiation of docetaxel therapy.
干预措施: docetaxel (Drug)
castrate resistant
Subjects with castrate resistant prostate cancer (CRPC) [defined as having evidence of prostate specific antigen (PSA) progression despite androgen deprivation therapy] that have had at least four weeks elapse between the withdrawal of anti-androgens (Bicalutamide, Flutamide or Nilutamide) and the initiation of docetaxel therapy.
干预措施: Blood draws (Other)
结局指标
主要结局
Docetaxel treatment related toxicities
时间窗: Up to 7 months after the initiation of docetaxel therapy
Determine the relationship between docetaxel plasma concentrations (i.e. exposure level) and the incidence of docetaxel related toxicities for identification of an optimal target docetaxel exposure range.
Variability of docetaxel exposure
时间窗: Up to 6 months after the initiation of docetaxel therapy
Blood will be drawn during the first six cycles of docetaxel therapy to determine the variability of docetaxel exposure.
次要结局
- Number of days hospitalized for treatment of docetaxel related toxicities(Up to 7 months after the initiation of docetaxel therapy)
- Frequency of growth factor usage(Up to 7 months after the initiation of docetaxel therapy)
- Time to prostate specific antigen (PSA) progression(Up to 24 months after the initiation of docetaxel therapy)
- Changes in quality of life(Up to 6 months after the initiation of docetaxel therapy)
- Overall survival(Up to 24 months after the initiation of docatexel therapy)
- Tumor response as determined by imaging(Up to 7 months after the initiation of docetaxel therapy)