The Effect of Multidisciplinary Care Approach on CV Risk Modification in CaP Patients Receiving ADT

Официальное название

To Investigate the Effect of Multidisciplinary Care Approach on Cardiovascular Risk Modification in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• The change in Framingham Risk Score between baseline and 1-year after ADT. [Срок оценки: From enrollment to 1-year after ADT]

Вторичные конечные точки (10)

• Incidence of new-onset diabetes [Срок оценки: From enrollment to 1-year after ADT]
• Incidence of new-onset hypertension [Срок оценки: From enrollment to 1-year after ADT]
• Changes in fasting blood sugar [Срок оценки: From enrollment to 1-year after ADT]
• Changes in LDL-Cholesterol [Срок оценки: From enrollment to 1-year after ADT]
• Changes in HDL-cholesterol [Срок оценки: From enrollment to 1-year after ADT]
• Changes in triglyceride [Срок оценки: From enrollment to 1-year after ADT]
• Changes in HbA1c [Срок оценки: From enrollment to 1-year after ADT]
• Incidence of additional medical therapies for optimization of cardiovascular risk [Срок оценки: From enrollment to 1-year after ADT]
• Change in pulse wave velocity [Срок оценки: From enrollment to 1-year after ADT]
• Change in Quality of life [Срок оценки: From enrollment to 1-year after ADT]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Гонконг · 1 центр

• The Chinese University of Hong Kong — Гонконг

Публикации

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• Lyon AR, Lopez-Fernandez T, Couch LS, Asteggiano R, Aznar MC, Bergler-Klein J, Boriani G, Cardinale D, Cordoba R, Cosyns B, Cutter DJ, de Azambuja E, de Boer RA, Dent SF, Farmakis D, Gevaert SA, Gorog DA, Herrmann J, Lenihan D, Moslehi J, Moura B, Salinger SS, Stephens R, Suter TM, Szmit S, Tamargo J, Thavendiranathan P, Tocchetti CG, van der Meer P, van der Pal HJH; ESC Scientific Document Group. PMID 36017568

Идентификаторы

NCT: NCT06163924 · CRE-2023.509

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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