Cardiotoxicity of Prostate Cancer Therapy: Mechanisms, Predictors, and Social Determinants of Health in Prostate Cancer Patients Treated With Androgen Deprivation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Left Ventricular Ejection Fraction (LVEF)
研究概览
简要总结
This is an observational study for patients with prostate cancer that will be treated with Androgen Deprivation Therapy. The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). Patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. Patients will be followed on this study for up to 5 years.
详细描述
The investigators propose a prospective longitudinal cohort of prostate cancer patients treated with Androgen Deprivation Therapy (ADT) to determine the associations between social determinants of health (SDOH) and cardiotoxicity risk and to determine wither associations between SDOH and cardiotoxicity risk differs according to race. Patients will be followed with serial echo, blood draw, and surveys prior to start of ADT and then 6 months, 1 year, 2 years, 3 years, and 5 years after start of ADT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Men older than 18 years of age Prostate cancer diagnosis planned for treatment with ≥6 months of ADT (with or without RT) for clinically localized, biochemically recurrent, or oligometastatic disease. Planned ADT regimens may include: GnRH agonists (goserelin, histrelin, leuprolide, triptorelin) with or without first-generation anti-androgens and GnRH antagonists (degarelix). Additional systemic agents, including second-generation androgen receptor signaling inhibitors, may be used in combination with GnRH agonist/antagonist therapies per provider clinical discretion.
- •Ability to provide informed consent
排除标准
- •Prior ADT injection within 6 months prior to enrollment Inability or unwillingness to provide consent
结局指标
主要结局
Change in Left Ventricular Ejection Fraction (LVEF)
时间窗: through study completion (expected to be 15 years)
Absolute change in LVEF by echocardiogram at follow-up
次要结局
- Change in Circumferential Strain(through study completion (expected to be 15 years))
- Change in Left Ventricular (LV) Mass(through study completion (expected to be 15 years))
- Change in Ventricular-Arterial Coupling(through study completion (expected to be 15 years))
- Cancer therapy-related cardiac dysfunction (CTRCD)(through study completion (expected to be 15 years))
- Symptomatic Heart Failure (HF)(through study completion (expected to be 15 years))
- Change in Longitudinal Strain(through study completion (expected to be 15 years))
- Change in Diastolic function(through study completion (expected to be 15 years))
- Change in Relative LV Wall Thickness(through study completion (expected to be 15 years))
- Change in LV Twist(through study completion (expected to be 15 years))
- Change in LV Torsion(through study completion (expected to be 15 years))
- Change in NTproBNP(through study completion (expected to be 15 years))
- Change in high-sensitivity troponin (hsTnT)(through study completion (expected to be 15 years))
- Change in patient reported fatigue(through study completion (expected to be 15 years))
- Change in patient reported quality of life(through study completion (expected to be 15 years))
- Change in patient reported activity level(through study completion (expected to be 15 years))