NCT03718338终止不适用
Mechanisms of Metabolic and Hormone Action on Plaque Formation in Brain and Carotid Vessels in Men Undergoing Androgen Deprivation Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change standardized uptake values of 18F-florbetapir (Amyvid) positron emission tomography (PET) scans results
研究概览
简要总结
This trial studies the mechanisms of metabolic and hormone action on plaque formation in brain and carotid vessels in patients with prostate adenocarcinoma. Studying the biomarkers in the laboratory may help doctors know the impact of androgen deprivation on metabolic, brain and cardiovascular endpoints.
详细描述
OUTLINE:
Patients undergo clinical evaluations over 12 months including physical exam and vital signs, waist to hip circumference, medical history and events, laboratory evaluations, imaging evaluations, cognitive function evaluations, gait assessment, and quality of life questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Histologically confirmed adenocarcinoma of the prostate
- •Non-castrate disease with a serum testosterone level >= 50 ng/dL (1.73 nmol/L) at baseline
- •No evidence of distant metastatic disease on baseline computed tomography-chest, abdomen and pelvis (CT-CAP) and bone scans
- •Patients will be stratified by the presence or absence of pre-existing cardiovascular disease defined as at least one of the following:
- •Prior myocardial infarction >= 30 days before enrollment
- •Prior revascularization procedure >= 30 days before consent, including:
- •Coronary artery stent placement or balloon angioplasty
- •Coronary artery bypass graft surgery
- •Stent placement or balloon angioplasty to a carotid, iliac, femoral, or popliteal artery
- •Carotid endarterectomy surgery
- •Vascular bypass surgery of the iliac, femoral, or popliteal artery
- •Results from angiogram or CT angiogram of coronary, carotic, iliac, femoral, or popliteal arteries that documents at least one vascular stenosis >= 50% at any time point before enrollment
- •Carotid ultrasound results that shows stenosis >= 50% at any time point before enrollment
- •Ankle-brachial pressure index < 0.9 at any time point before enrollment
- •Intent to initiate continuous androgen deprivation therapy (ADT) for at least 12 months
排除标准
- •No prior treatment with ADT at time of study entry. (Prior neoadjuvant/adjuvant ADT is allowed only if the last injection of a depot formulation wore off at least 12 months prior to enrollment)
- •Previous or concurrent hormonal or systemic therapy for prostate cancer including: anti-androgens, estrogens, megestrol acetate, ketoconazole, abiraterone, enzalutamide, or chemotherapy. (Prior or planned neoadjuvant bicalutamide for prevention of tumor flare is allowed)
- •Plans to start or continue treatment with an investigational product after enrollment
- •Poorly controlled type 1 or type 2 diabetes mellitus, based on hemoglobin A1c, as judged by the investigator
- •Prior or planned surgical castration
- •Poorly controlled hypertension at time of study entry, as judged by the investigator
- •Myocardial infarction or stroke < 30 days prior to enrollment
- •Coronary, carotid, or peripheral artery revascularization < 30 days prior to enrollment
- •Planned or scheduled cardiac surgery or percutaneous coronary intervention (PCI) procedure that is known at the time of enrollment
- •Mental incapacity or language barrier precluding adequate understanding or cooperation
- •Inability to tolerate magnetic resonance imaging (MRI) imaging, or both Lupron and Degarelix
- •Any other clinically significant disorder which may affect the subject's health or the outcome of the trial as judged by the investigator
- •Estimated glomerular filtration rate (eGFR) < 45
- •History of allergy to gadolinium contrast agent
结局指标
主要结局
Change standardized uptake values of 18F-florbetapir (Amyvid) positron emission tomography (PET) scans results
时间窗: 12 Months
Change from baseline standardized uptake values in select regions of interest at 12 months
Change in visual characterization of 18F-florbetapir (Amyvid) positron emission tomography (PET) scans results after Andorgen Deprivation Therapy
时间窗: 12 Months
Change From Baseline visual characterization scan results at 12 months
次要结局
- Cognitive Test Results: Visuo-Spatial Learning Test(12 Months)
- Inflammatory and immune markers: Change in CRP(12 Months)
- Inflammatory and immune markers: Change in IGFBP1(12 Months)
- Cognitive Test Results: Stroop Test Results(12 Months)
- Metabolic Markers: Change in HgbA1C(12 Months)
- Metabolic Markers: Change in Follicle Stimulating Hormone (FSH)(12 Months)
- Metabolic Markers: Change in Leptin(12 Months)
- Cognitive Test Results: Change in Montreal Cognitive Assessment (MOCA)(12 Months)
- Cognitive Test Results: Change in Clinical Dementia Rating Scale(12 Months)
- Cognitive Test Results: Letter number sequencing(12 Months)
- Cognitive Test Results: Symbol Digit Modalities Test(12 Months)
- Cognitive test results: Story recall(12 months)
- Cognitive Test Results: Digit span(12 Months)
- Cognitive Test Results: Rey auditory verbal learning test (RVLT)(12 Months)
- Inflammatory and immune markers: Change in IGFBP3(12 Months)
- Metabolic Markers: Change in Estradiol(12 Months)
- Metabolic Markers: Change in Adiponectin(12 Months)
- Inflammatory and immune markers: Change in IGF-1(12 Months)
- Metabolic Markers: Change in homeostatic model assessment of insulin resistance (HOMA-IR)(12 Months)
- Inflammatory and immune markers: Change in IL-6(12 Months)
研究者
研究点 (1)
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