Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Castrate Level of Serum Testosterone
研究概览
简要总结
The goal of this study is to find out if patients with prostate cancer being treated with the medications abiraterone and prednisone can discontinue hormone injections (examples include leuprolide, goserelin, triptorelin and degarelix). Abiraterone and prednisone are pills used to treat patients with prostate cancer. When abiraterone and prednisone are used, hormone injections are usually continued to maintain a low testosterone level in the blood. This study is being done to find out if testosterone in the blood will stay low while abiraterone and prednisone are used without continued hormone injections.
详细描述
Abiraterone inhibits the CYP17A enzyme, which is a critical enzyme in androgen biosynthesis. Abiraterone has regulatory approval in metastatic castration-resistant prostate cancer (mCRPC) in both chemotherapy-naïve and in the post-docetaxel setting based upon results from two randomized phase III studies. Abiraterone is also proven to extend survival in the metastatic, hormone-naïve population based on two phase III studies. Abiraterone is a castrating agent, but, other than a small first in human study, all clinical studies have been done in conjunction with gonadotropin-releasing hormone (GnRH) analogues. Maintaining castrate level of serum testosterone is critical in the treatment of metastatic prostate cancer. It is unknown if GnRH analogues must be continued to maintain castrate levels of serum testosterone in patients treated with abiraterone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •The patient must be able to provide study-specific informed consent prior to study entry
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •Pathologically proven diagnosis of prostate adenocarcinoma
- •Patients must have metastatic prostate cancer
- •Patients may have mCRPC or may have metastatic castration-sensitive disease.
- •Patients must be maintained on a GnRH analogue (agonist (leuprolide, goserelin, triptorelin, histrelin, deslorelin) or antagonist (degarelix))
- •The patient and the investigator have decided that the next line of cancer therapy will be abiraterone plus prednisone and the initial dose of abiraterone will be 1000 mg daily. Or patients may already be on abiraterone with prednisone at a dose of 1000 mg daily along with a GnRH analogue.
- •Lab values meeting the following criteria
- •Total testosterone level of <50 ng/dl
- •Total bilirubin < 2.0 X Upper Limit of Normal (ULN)
- •Aspartate aminotransferase (AST) ≤ 3 X ULN
- •Alanine aminotransferase (ALT) ≤ 3 X ULN
- •Absolute Neutrophil Count > 1.5 K/mm3
- •Platelets > 100 K/mm3
- •Hemoglobin ≥ 9.0 g/dL
- •Calculated creatinine clearance ≥ 30 mL/min
排除标准
- •History of bilateral orchiectomy
- •History of hypopituitarism
- •For patients not yet started on abiraterone with prednisone, uncontrolled hypertension (systolic blood pressure >170 mm Hg or diastolic blood pressure >100 mm Hg)
- •Patients must not have New York Heart Association Class III or IV heart failure at the time of screening. Patients must not have any unstable angina, myocardial infarction, or serious uncontrolled cardiac arrhythmia within 6 months prior to registration
- •Any other serious illness or medical condition that the principal investigator feels would make the patient a poor candidate for this study
研究组 & 干预措施
Abiraterone and Prednisone without a GnRH Analogue
Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection
干预措施: Abiraterone Acetate (Drug)
Abiraterone and Prednisone without a GnRH Analogue
Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection
干预措施: Prednisone (Drug)
结局指标
主要结局
Percentage of Patients With Castrate Level of Serum Testosterone
时间窗: Approximately 24 weeks
The number/percentage of patients with a castrate serum testosterone level, defined as having a serum castrate concentration \<50 ng/dL when Abiraterone acetate plus prednisone (AAP) is used without GnRH analogues in metastatic prostate cancer, will be determined. Results are summarized as a number/percentage of participants.
次要结局
- Serum Testosterone (T) Levels(Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment)
- Serum Luteinizing Hormone (LH) Levels(Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment)
- Prostate-specific Antigen (PSA) Response(Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment)
- Treatment-related Adverse Events Due to Toxicity(24 weeks)
- Radiographic Progression-free Survival (rPFS)(From initiation of treatment to the end of treatment, up to approximately 41 months (~178 weeks))
- Overall Survival (OS)(From initiation of treatment until the end of treatment, up to approximately 41 months)
研究者
Benjamin Gartrell
Principal Investigator
Montefiore Medical Center