Investigator-Initiated Pilot Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Apoptotic Indices Before and After Treatment
研究概览
简要总结
The purpose of this study is to look at blood and tissue samples for changes following the use of Sunitinib malate. Additionally, we would like to find out if the drug, Sunitinib malate, is safe and works in men with prostate cancer. Sunitinib malate , also known as Sutent, is approved by the U.S. Food and Drug Administration (FDA), for treatment of tumors of intestines and kidney but it is being tested in research studies for use in men with prostate cancer.
详细描述
Eligible patients will be treated with 50 mg once daily for four weeks followed by one to two weeks off treatment prior to undergoing radical prostatectomy. Patients with palpable disease (cT2-3) and patients with 3 or more positive prostatic biopsies from one lobe may undergo an additional study of IFP monitoring before treatment and during week 4 of study treatment. Safety and tolerability of Sunitinib malate therapy at this dose and schedule in this patient population will be assessed. Extensive correlative science evaluations, including assessment of physiologic, cellular, molecular and genetic changes during treatment with Sunitinib malate, will be performed
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologic evidence of adenocarcinoma of the prostate deemed candidates for curative RRP
- •Intermediate or high risk, clinically localized disease
- •Adequate organ function
- •Patients must be surgically sterile or must agree to use effective contraception during the period of therapy
- •Select imaging to rule out metastasis will be done as clinically indicated
- •Signed and date informed consent document
排除标准
- •Prior treatment for prostate cancer
- •Major surgery or radiation therapy within 4 weeks of starting the study treatment
- •NCI CTCAE grade 3 hemorrhage within 4 weeks of starting therapy
- •History of or known metastatic prostate cancer
- •Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- •Ongoing cardiac dysrhythmias of NCI CTCAE grade 2 or greater
- •QTc interval > 500 msec on baseline EKG
- •Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy).
- •Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- •Known active infection
- •Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
研究组 & 干预措施
Sunitinib Malate
Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks
干预措施: Sunitinib Malate (Drug)
结局指标
主要结局
Change in Apoptotic Indices Before and After Treatment
时间窗: Baseline and 4 weeks
Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %apoptosis (measured as %TUNEL positive cells per high powered field) between pre and post treatment will be reported.
Change in Proliferation Indices Before and After Treatment
时间窗: Baseline and 4 weeks
Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %proliferation (Ki67 positive nuclei out of total nuclei) between pre and post treatment will be reported.
次要结局
- Interstitial Fluid Pressure (IFP)(4 years)
- Number of Patients Experiencing Grade ≥4 Hematologic or Grade ≥3 Non-hematologic Toxicity(4 years)
- Change in Pathologic (Microvessel Density).(Baseline and 4 weeks)
- Change in Systemic Parameters Before and After Sunitinib Malate Treatment.(Baseline and 4 weeks)
- Protein Levels and Activation Status of PDGFR in Prostate Cancer Tissue.(4 years)
- Difference in Gene Expression Patterns Using Microarray Analysis(4 years)