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

NCT06163924 · Chinese University of Hong Kong
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Official title
To Investigate the Effect of Multidisciplinary Care Approach on Cardiovascular Risk Modification in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
About this study
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.
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Study design
Enrollment target: 130 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-12-10
Estimated completion: 2029-03-31
Last updated: 2025-05-06
Primary outcomes
  • The change in Framingham Risk Score between baseline and 1-year after ADT. (From enrollment to 1-year after ADT)
Sponsor
Chinese University of Hong Kong · other
Contacts & investigators
ContactChi Fai NG, Professor · contact · ngcf@surgery.cuhk.edu.hk · 852-3505-3933
All locations (1)
The Chinese University of Hong KongRecruiting
Hong Kong, Hong Kong
The Effect of Multidisciplinary Care Approach on CV Risk Modification in CaP Patients Receiving ADT · TrialPath