Phase 2 Study of Enzalutamide and GnRH Agonist Before, During and After Radiation Therapy in Treatment of Patients With High-risk Localized Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Safety, as Measured by the Number of Patients With at Least One Adverse Event as Assess by NCI Common Terminology Criteria for Adverse Events (CTCAE) vs. 40 When Combining Enzalutamide With a GnRH and External Beam Radiation
研究概览
简要总结
The study is being done to find out whether combining two FDA approved drugs along with radiation therapy for the treatment of high risk localized prostate cancer is safe and well tolerated.
详细描述
- this pilot study will assess the safety and tolerability of combining enzalutamide with an gonadotropin-releasing hormone agonist (GnRH) and external beam radiation
- Correlative imaging and tissue biopsy analysis will be performed to assess the radiographic response to enzalutamide plus gonadotropin-releasing hormone agonist (GnRH) therapy as well as intratumoral androgen signaling
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 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •histologically proven adenocarcinoma of the prostate within 6 months of screening
- •Eastern Cooperative Oncology Group(ECOG) score 0-2
- •adequate organ and and blood marrow function
- •must be a candidate for long-term androgen deprivation in combination with external beam radiation for the treatment of high risk prostate cancer
- •patient must permit a targeted prostate biopsy at the time of study initiation or at the beginning of radiation treatment
- •men who are sexually active with female partners of child-bearing potential mush agree to use adequate contraception
排除标准
- •prior treatment with agents known to have endocrine effects on prostate cancer
- •treatment with corticosteroids within 4 weeks of enrollment
- •treatment with androgens within 6 months of enrollment
- •may not be receiving any other investigational agents
- •Prostate specific antigen greater than 160ng/dL
- •history of malignancy( other than non-melanoma skin cancer) within 5 years
- •uncontrolled intercurrent illness
- •cardiovascular event within 6 months of enrollment
- •seizure or seizure disorder history
- •contraindications to MRI- pacemakers, clips, etc
研究组 & 干预措施
Enzalutamide, Leuprolide, radiation
Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care
干预措施: Enzalutamide (Drug)
Enzalutamide, Leuprolide, radiation
Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care
干预措施: Leuprolide acetate (Drug)
Enzalutamide, Leuprolide, radiation
Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care
干预措施: radiation (Radiation)
结局指标
主要结局
Safety, as Measured by the Number of Patients With at Least One Adverse Event as Assess by NCI Common Terminology Criteria for Adverse Events (CTCAE) vs. 40 When Combining Enzalutamide With a GnRH and External Beam Radiation
时间窗: 12 months following initiation of treatment with enzalutamide plus GnRH agonist
Assessment will number of participants who experience adverse events greater than or equal to Grade 3, as defined by NCI Common terminology criteria for adverse events(CTCAE) v4.0
次要结局
- Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy(12 months)
研究者
Kevin Dale Courtney
Associate Professor of Medicine
University of Texas Southwestern Medical Center