NCT02737332已完成2 期
A Randomized, Open-Label, Active-Controlled, Multi-Center Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer: The STAAR STUDY
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 17
- 主要终点
- Testosterone Levels
研究概览
简要总结
The purpose of this study is to evaluate the serum testosterone levels in patients with Metastatic Castration-Resistant Prostate Cancer on SoluMatrix™ Abiraterone Acetate as Compared to Abiraterone Acetate
详细描述
This was a 12-week, open-label study of abiraterone acetate in at least 50 patients with metastatic castration-resistant prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Written informed consent obtained prior to any study-related procedure being performed
- •Male subjects at least 18 years of age or older at time of consent
- •Pathologically confirmed adenocarcinoma of the prostate
- •Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level <50 ng/dL at screening
- •Metastatic disease documented by computed tomography (CT)/ magnetic resonance imaging (MRI) or bone scan. Imaging obtained within 42 days prior to the start of study medication will be accepted.
- •Meeting disease progression according to the recommendations of the prostate cancer working group 2 by one of the following criteria:
- •Two rises of PSA (taken a minimum of 1 week apart) from a baseline measurement of at least 2 ng/mL,
- •Imaging progression (CT/MRI) by RECIST criteria
- •Nuclear scan progression by new lesion.
- •Discontinuation of flutamide or nilutamide, and other anti-androgens at least 4 weeks prior to the start of study medication; discontinuation of bicalutamide at least 6 weeks prior to start of study medication.
- •Discontinuation of Radiotherapy > 4 weeks prior to start of study medication.
- •ECOG performance status of 0-1 at screening
- •Screening blood counts of the following:
- •Absolute neutrophil count > 1500/µL
- •Platelets > 100,000/µL
- •Hemoglobin > 9 g/dL
- •Screening chemistry values of the following:
- •ALT and AST < 2.5 x ULN
- •Total bilirubin < 1.5 x ULN
- •Creatinine< 1.5 x ULN
- •Albumin > 3.0 g/dL
- •Potassium > 3.5 mmol/L
- •Life expectancy of at least 6 months at screening
- •Subject is willing and able to comply with all protocol requirements assessments
- •Agrees to protocol-defined use of effective contraception.
排除标准
- •History of impaired pituitary or adrenal gland function
- •Prior therapy with abiraterone acetate, orteronel, ketoconazole or any other CYP17 inhibitor
- •Prior therapy with enzalutamide
- •Prior use of experimental androgen receptor antagonist
- •Previous exposure to Ra-223:Xofigo
- •Previous chemotherapy
- •Initiation of bisphosphonate or denosumab therapy within 30 days prior to the start of study medication. Patients who are on a stable dose of these medications for at least 30 days at the time of starting study drug are eligible.
- •Therapy with estrogen within 30 days prior to the start of study medication
- •Use of systemic glucocorticoids equivalent to > 10 mg of prednisone daily; patients who have discontinued or have reduced dose to < 10 mg prednisone within 14 days prior to the start of study medication will be eligible
- •Prior use of any herbal products that may decrease PSA levels (eg., saw palmetto) within 30 days of start of study medication
- •Known metastases to the brain or CNS involvement
- •History of other malignancy within the previous 2 years
- •Major surgery within 30 days prior to the start of study medication
- •Blood transfusion within 30 days of screening
- •Serious, persistent infection within 14 days of the start of study medication
- •Persistent pain that requires the use of a narcotic analgesic
- •Known gastrointestinal disease or condition that may impair absorption
- •Treatment with any investigational drug within 4 weeks prior to Day -1 of the study.
- •Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus
- •Have poorly controlled diabetes.
- •Uncontrolled hypertension
- •History of New York Heart Association (NYHA) class III or IV heart failure
- •Serious concurrent illness, including psychiatric illness, that would interfere with study participation
- •Inability to swallow tablets whole
- •Known hypersensitivity to any excipients in study medications
- •Moderate to severe hepatic impairment (Child-Pugh Classes B and C)
研究组 & 干预措施
Zytiga® (Abiraterone Acetate)
Active Comparator
1,000 MG (4 x 250 mg qd)
干预措施: Zytiga® (Abiraterone Acetate) (Drug)
SoluMatrix™ (Abiraterone Acetate)
Experimental
500 mg (4 x 125 mg qd)
干预措施: SoluMatrix™ (Abiraterone Acetate) (Drug)
结局指标
主要结局
Testosterone Levels
时间窗: Average of Day 9 and 10
Blood Sample tested for Serum Testosterone Levels
次要结局
- Steady State Trough Concentration of Arbiraterone(Day 09, Day 28, Day 56, and Day 84)
- AUC (0-inf)(60 to 30 minutes prior to dosing and over 24 Hours post-dose)
- AUC (0-24 hr)(60 to 30 minutes prior to dosing and over 24 Hours post-dose)
- AUC (0-t)(60 to 30 minutes prior to dosing and over 24 Hours post-dose)
- Cmax(60 to 30 minutes prior to dosing and over 24 Hours post-dose)
- PSA Levels(Day 28, Day 56, and Day 84)
- Percent of Subjects With PSA-50 Response(Day 28, Day 56, and Day 84)
- Serum Testosterone Levels(Day 28, Day 56, and Day 84)
研究者
研究点 (17)
Loading locations...
相似试验
已完成
2 期
Testosterone in Metastatic Renal Cell Carcinoma PatientsMetastatic Renal Cell CarcinomaNCT03379012Kidney Cancer Research Bureau60
已完成
2 期
Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate CancerProstate CancerCastration-resistant Prostate CancerMetastatic Castration-resistant Prostate CancerNCT05081193Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins15
已完成
1 期
An Open-Label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62% Applied to the Upper Arms and Shoulders and Use of a T-shirt BarrierHealthyNCT01130298AbbVie24
已完成
不适用
A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men With Castration Resistant Prostate CancerProstate CancerNCT01084759Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins16
终止
4 期
Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate CancerProstate CancerNCT02749825Pharmatech41