NCT03305224Unknown2 期
The Study of Combination Therapy With Radium-223 and Enzalutamide in Osaka City University
Taro Iguchi, MD, PHD1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年10月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in Alkaline phosphatase (ALP)
研究概览
简要总结
This study is to evaluate preliminary efficacy of Ra-223 in combination with Enzalutamide in progressive CRPC patients with bone metastasis
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as CRPC
- •Surgical or those who will be treated with luteinizing hormone-releasing hormone (LHRH) agonists throughout the study period,
- •Patients who had >30% of PSA response to enzalutamide prior to enrollment,
- •Interval between PSA progression and enrollment is up to 3 months,
- •With bone metastases (≥ 2 hot spots) on bone scintigraphy within previous 24 weeks,
- •No intention to use anti-cancer chemotherapy within the next 6 months,
- •Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-1,
- •Life expectancy ≥ 6 months,
- •Laboratory requirements within 30 days before enrollment:
- •Absolute neutrophil count (ANC) ≥ 1.5 x 10e9/L,
- •Platelet count ≥ 100 x 10e9/L,
- •Hemoglobin ≥ 10.0 g/dL,
- •Total bilirubin level ≤1.5 institutional upper limit of normal (ULN),
- •Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 ULN,
- •Creatinine ≤ 1.5ULN, and estimated glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2,
- •Ability to understand and the willingness to sign a written informed consent (IC).
排除标准
- •Prior chemotherapy or planned treatment with chemotherapy,
- •PSA progression within 3 months after initiation of enzalutamide
- •Prior treatment with corticosteroids, estramustine or abiraterone acetate,
- •Any systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bone metastases,
- •Had history of gastrointestinal bleeding or ulcer within 3 months prior to study entry,
- •History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations,
- •History of or known brain metastasis,
- •Malignant lymphadenopathy ≧1.5 cm in short axis,
- •Imminent or established spinal cord compression based on clinical findings and/or MRI (Magnetic Resonance Imaging),
- •Any other serious illness or medical condition
- •Substance abuse, medical, psychological, or social conditions that might interfere with the subject's participation in the study or evaluation of the study Results
- •Those who judged to be inappropriate by the principal investigator or co-investigator.
研究组 & 干预措施
Ra-223 + Enzalutamide
Other
干预措施: Ra-223 in combination with enzalutamide (Drug)
结局指标
主要结局
Changes in Alkaline phosphatase (ALP)
时间窗: 6 months
Percentage of change from baseline to 6 months (or earlier for those who discontinue study therapy)
次要结局
- Evaluation for bone metastasis by bone scintigraphy(1, 3, 6 months)
- Tolerability of Radium-223 therapy(6 months)
- Evaluation for bone metastasis by 18F-NaF-PET(1, 3, 6 months)
- Overall Survival Rate(3 years)
- Time to occurrence of visceral metastasis(1 year)
- Time to occurrence of Symptomatic Skeletal-related Events (SSEs)(1 year)
- Time to initiation of cytotoxic chemotherapy(1 year)
- Changes in Prostate Specific Antigen (PSA)(6 months)
- Changes From Baseline for Brief Pain Inventory (BPI)(6 months)
- Changes From Baseline for Functional Assessment of Cancer Therapy - Prostate (FACT-P)(6 months)
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(6 months)
研究者
Taro Iguchi, MD, PHD
Principal Investigator
Osaka City University
研究点 (1)
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