NCT02430480已完成2 期
Neoadjuvant Androgen Deprivation and Enzalutamide: Using Multiparametric MRI to Evaluate Intraprostatic Tumor Responses and Androgen Resistance Patterns in Newly Diagnosed Prostate Cancer
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
- 39
- 试验地点
- 1
- 主要终点
- Median Tumor Volume Burden at Baseline Multi-parametric Magnetic Resonance Imaging (mpMRI) Before and After Surgery
研究概览
简要总结
Background:
- There are several ways to treat prostate cancer. Researchers want to see how well a certain kind of imaging helps detect prostate cancer. They also want to see if a particular drug combination used before surgery will benefit people with prostate cancer that hasn't spread in the body (non-metastatic). The combination will be androgen deprivation therapy and enzalutamide.
- The combination of androgen deprivation therapy and enzalutamide has been shown to make patients with advanced (metastatic disease) live longer. The investigators want to see if using it earlier can increase cure rate of surgery and identify genetic or molecular characteristics that are associated with better outcomes.
Objectives:
- To develop better ways of detecting prostate cancer before and after pre-operative treatment.
Eligibility:
- Men at least 18 years old with non-metastatic prostate cancer. They must be candidates for a radical prostatectomy.
Design:
- Participants will be screened with medical history, physical exam, and blood tests. They will have scans and X-rays.
- Before starting the study drugs, participants will have:
- Vital signs taken, medical history, and blood tests.
- Electrocardiogram (ECG) heart test, with patches stuck on the skin.
- Small piece of tumor removed (biopsy) using image guidance from magnetic resonance imaging (MRI) and ultrasound.
- 3T multi-parametric magnetic resonance imaging (mpMRI). Participants will lie on a table that slides into a metal cylinder. A probe will be inserted in the rectum. They will be in the scanner for about 60 minutes, lying still. The scanner makes loud knocking sounds. Participants will get earplugs.
- Participants will take the 2 study drugs for 6 months.
- Enzalutamide is taken as 4 pills once a day.
- Androgen deprivation therapy is given by injection 2 times over 6 months.
- During these 6 months, participants will visit the clinic monthly. They will have physical exam, vital signs, and blood drawn.
- After finishing the study drugs, participants will have another 3T mpMRI. Then they will have prostate removal surgery.
详细描述
Background:
- Most men diagnosed with prostate cancer will present with intermediate or high-risk disease
- Many develop castrate resistant prostate cancer (CRPC) as curative strategies are often unsuccessful
- Treatment options typically involve radical prostatectomy (RP) or radiation therapy (RT) in combination with androgen deprivation therapy (ADT)
- Even when cancers are initially sensitive to ADT, resistance ultimately emerges either through clonal selection or through a variety of adaptive mechanisms (secondary resistance).
- The recent introduction of novel androgen pathway inhibitors offers an opportunity to potentially improve the cure rate of men with intermediate and high risk localized prostate cancer
- There remains a great need for improved techniques to determine mechanisms of treatment response and resistance.
Objectives:
-To test the feasibility of multi parametric magnetic resonance imaging (mpMRI) for the localization and detection of focal prostate cancer both before and after pre-operative treatment with ADT and enzalutamide.
Eligibility:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1/Arm 1- Enzalutamide and Goserelin
Experimental
Patients will have an multi-parametric magnetic resonance imaging (mpMRI) guided biopsy, then receive enzalutamide and goserelin subcutaneous (SC) treatment for 6 months followed by a second mpMRI examination.
干预措施: Goserelin (Drug)
1/Arm 1- Enzalutamide and Goserelin
Experimental
Patients will have an multi-parametric magnetic resonance imaging (mpMRI) guided biopsy, then receive enzalutamide and goserelin subcutaneous (SC) treatment for 6 months followed by a second mpMRI examination.
干预措施: Enzalutamide (Drug)
1/Arm 1- Enzalutamide and Goserelin
Experimental
Patients will have an multi-parametric magnetic resonance imaging (mpMRI) guided biopsy, then receive enzalutamide and goserelin subcutaneous (SC) treatment for 6 months followed by a second mpMRI examination.
干预措施: mpMRI (Device)
结局指标
主要结局
Median Tumor Volume Burden at Baseline Multi-parametric Magnetic Resonance Imaging (mpMRI) Before and After Surgery
时间窗: Baseline and 6 months
The prostate lesion is contoured manually by an expert radiologist. Research software (mim-vista) calculates the volume. Greater tumor volumes may indicate higher prostate tumor growth.
次要结局
- Initial Multiparametric Magnetic Resonance Imaging (mpMRI) Percentage of Relative Tumor Volume Sensitivity(6 months)
- Number of Participants With Reduction in Phosphatase and Tensin Homolog (PTEN) Levels(post treatment, approximately 1-3 months)
- Median Prostate Lesion Volume Before and After Treatment(Baseline and 6 months)
- Median Nuclear Androgen Receptor (AR) Level in Biopsy Specimens Versus Residual Tumors(6 months)
- Number of Participants With a Complete Response(After neoadjuvant treatment with androgen deprivation therapy (ADT) and enzalutamide, approximately 6 months)
- Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)(Date treatment consent signed to date off study, approximately 51 months and 2 days.)
- Number of Prostate Lesions Detected Within the Study Population at Baseline Multi-parametric Magnetic Resonance Imaging (mpMRI) and 6 Months After Enzalutamide Plus Androgen Deprivation Therapy (ADT)(Baseline and 6 months)
- Number of Participants With Positive Erythroblast Transformation-specific (ETS)-Related Gene (ERG) Protein Overexpression(Approximately one month-3 months post-treatment)
- Initial Multiparametric Magnetic Resonance Imaging (mpMRI) Percentage of Relative Tumor Volume Specificity(6 months)
研究者
Fatima Karzai, M.D.
Principal Investigator
National Cancer Institute (NCI)
研究点 (1)
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