NCT02758132终止2 期
Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases: Clinical Testing and Feasibility of a Serum-based Metabolomics Profile
University of Hawaii1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2016年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Measure Change in Serum-based Metabolites Associated With Bone Deposition, Growth and Turnover in Patients Who Have CRPC With Clinical Evidence of Metastatic Disease to the Bone, All Using Gas Chromatography-time-of-flight Mass Spectrometry (GC-TOFMS).
研究概览
简要总结
This is a correlative study to characterize serum metabolites associated with bone deposition, growth and turnover in patients with newly diagnosed metastatic CRPC who are not currently receiving bone targeting agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Histologic proof of adenocarcinoma of the prostate with clinical evidence of metastatic disease to the bone.
- •Castrate resistant progression of prostate carcinoma, as shown by:
- •Serum testosterone level <50 ng/dL or prior bilateral orchiectomy. Treatment to maintain castrate levels of testosterone should continue, and
- •Either symptomatic progression, or, if patient is asymptomatic then a rising serum PSA in two occasions at least 1 week apart, with minimum pre-treatment serum PSA of 5 ng/dL.
- •Patients with nodal disease are eligible.
- •Bi-dimensionally measurable disease within the bone.
- •Life expectancy of at least 12 weeks.
- •ECOG Performance status < 2
- •Adequate:
- •Bone marrow function; absolute neutrophil count > 1,500 mm3, platelet count of > 100,000 mm3 and hemoglobin > 9.0 gm/dl.
- •Hepatic function; SGOT/SGPT and conjugated bilirubin less than twice the upper limit of normal.
- •Renal function; serum creatinine ≤ 2 mg/dL (or, if creatinine > 2 mg/dL, then a creatinine clearance of at least 35 ml/min (measured or estimated by the Cockroft formula:
- •CLcr = [(140-age) x wt (kg)]/[72 x serum creatinine (mg/dL)].
- •No evidence of coagulopathy as indicated by PT < 1.5X upper limit of normal.
- •Serum calcium (corrected) from 8 to11.5 mg/dL (2 to 2.9 mmol/L) - Patients must sign an informed consent indicating that they are aware of the investigational nature of the study.
排除标准
- •Patients with variant histologies (e.g., ductal or small cell carcinoma).
- •Patients with visceral disease are ineligible.
- •Patients who have had prior Sipuleucel-T, docetaxel, cabazitaxel, abiraterone or enzalutamide as a single agent, or in combination therapy.
- •Concurrent cancer chemotherapy, radiotherapy or surgery.
- •Concurrent serious infection.
- •Life threatening illness (e.g., congestive heart failure, uncontrolled angina or myocardial infarction in the prior six months).
- •Hypertension uncontrolled by medication.
- •Patients who are known to require invasive dental procedures.
- •No known or suspected brain metastases (NOTE: patients with treated epidural disease are allowed)
- •Administration of any investigational drug within 28 days prior to receipt of denosumab.
- •Age ≤ 18 years of age
研究组 & 干预措施
Alliance A031201
Active Comparator
Denosumab plus enzalutamide, abiraterone and prednisone
干预措施: Denosumab (Biological)
Alliance A031201
Active Comparator
Denosumab plus enzalutamide, abiraterone and prednisone
干预措施: Enzalutamide (Drug)
Alliance A031201
Active Comparator
Denosumab plus enzalutamide, abiraterone and prednisone
干预措施: Abiraterone (Drug)
Alliance A031201
Active Comparator
Denosumab plus enzalutamide, abiraterone and prednisone
干预措施: Prednisone (Drug)
Standard of Care
Active Comparator
Denosumab plus enzalutamide alone
干预措施: Denosumab (Biological)
Standard of Care
Active Comparator
Denosumab plus enzalutamide alone
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Measure Change in Serum-based Metabolites Associated With Bone Deposition, Growth and Turnover in Patients Who Have CRPC With Clinical Evidence of Metastatic Disease to the Bone, All Using Gas Chromatography-time-of-flight Mass Spectrometry (GC-TOFMS).
时间窗: Prior to Registration, Registration, Day 1 of cycle 4 and 13
次要结局
- Measure Time (Months) to Duration of Response of Patients on Therapy.(Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment)
- Measure Time (Months) to Skeletal Related Event (SRE) of Patients on Therapy(Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment)
- Measure Time (Months) to Progression-free Survival of Patients on Therapy(Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment)
研究者
研究点 (1)
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