To Investigate the Effect of Multidisciplinary Care Approach on Cardiovascular Risk Modification in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- The change in Framingham Risk Score between baseline and 1-year after ADT.
研究概览
简要总结
Prostate cancer is characterised by its slow progression nature, and even for metastatic disease, the 5-year survival is up to 30%. While ADT can effectively control disease, there is increasing evidence suggesting that it can also result in many adverse cardiovascular side effects on the patients, and these effects are particularly important due to the prolonged survival of these patients. There are suggestions that close cardiovascular (CV) monitoring will help to reduce cardiovascular risk and related morbidities. However, there is limited data to show the positive impact of these monitoring could reducing CV risk and morbidities. Moreover, information regarding the optimal follow-up approach and schedule is also lacking. Therefore, there is a need to have more information on the approach to monitoring the CV risk and the real-life impact of this monitoring on our patients. Patients diagnosed with prostate cancer and plan to receive ADT are invited to participate in this study to assess the potential benefit of multidisciplinary care approach to CV risk modification.
详细描述
Prostate Cancer (PCa) and androgen deprivation therapy (ADT) PCa is the most common cancer and the second leading cancer death in adult male globally. In Hong Kong, it is one of the most rapidly increasing cancer and is now the third most common cancer and the 4th leading cancer death in male. Despite the increased usage of serum PSA for early cancer diagnosis, more than 50% of patients were diagnosed at stage III & IV, with lymph node +/- bone / visceral metastasis. Therefore, ADT is still commonly used in PCa patients, both as neo-adjuvant/ adjuvant to radiotherapy,as well as backbone therapy for metastatic disease.While the overall survival of PCa patients has been prolonged by ADT, there is also increasing concern about potential long-term side effects, in particular cardiovascular effect.
Therefore, there is a need for prospective studies to understand the role of close cardiovascular assessment, monitoring and treatment on the cardiovascular risk of PCa patients receiving ADT. Information on the risk factors at baseline; follow-up, and also treatment / secondary prevention adopted, will help to provide evidence to fill the current knowledge gap and build practical guidelines for clinical usage. In the long run, the data will also help to estimate the medical resources required for future health care planning to cope with the medical needs of the rapidly increasing PCa population.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult men 18-80 years old
- •With histological proven prostate cancer or clinically diagnosed to have prostate cancer,
- •Planned for ADT for at least 1 year
排除标准
- •Subjects with established major atherosclerotic cardiovascular disease (ASCVD) as defined by a recent acute coronary syndrome within the past 12 months, a history of myocardial infarction other than the recent acute coronary syndrome event, a history of ischemic stroke, and symptomatic peripheral arterial disease (defined as history of claudication with ankle-brachial index <0.85 or previous revascularization or amputation
- •Prior neoadjuvant or adjuvant hormone therapy within 1 year before
- •Refuse or unable to give written informed consent
- •Participation in an investigational program with interventions outside of routine clinical practice
结局指标
主要结局
The change in Framingham Risk Score between baseline and 1-year after ADT.
时间窗: From enrollment to 1-year after ADT
The Framingham Risk Score is a gender-specific algorithm based on multiple cardiovascular risk factors including age, smoking status, blood pressure level, serum total cholesterol and HDL-cholesterol level for the estimation of the 10-year risk of developing cardiovascular disease. This remain a commonly used assessment for cardiovascular risk, including PCa patients treated with ADT internationally.
次要结局
- Changes in HDL-cholesterol(From enrollment to 1-year after ADT)
- Incidence of new-onset diabetes(From enrollment to 1-year after ADT)
- Changes in triglyceride(From enrollment to 1-year after ADT)
- Incidence of additional medical therapies for optimization of cardiovascular risk(From enrollment to 1-year after ADT)
- Change in pulse wave velocity(From enrollment to 1-year after ADT)
- Incidence of new-onset hypertension(From enrollment to 1-year after ADT)
- Changes in fasting blood sugar(From enrollment to 1-year after ADT)
- Changes in LDL-Cholesterol(From enrollment to 1-year after ADT)
- Changes in HbA1c(From enrollment to 1-year after ADT)
- Change in Quality of life(From enrollment to 1-year after ADT)
研究者
NG Chi Fai
Professor
Chinese University of Hong Kong