The Effect of Multidisciplinary Care Approach on CV Risk Modification in CaP Patients Receiving ADT
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-80
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
prostate cancer patients receiving androgen deprivation therapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
130 Participants
are grouped into 1 trial groupGroup A: PCa receiving ADT
Trial outcomes
Primary outcomes
1
The change in Framingham Risk Score between baseline and 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.
Time frame
From enrollment to 1-year after ADTSecondary outcomes
1
Incidence of new-onset diabetes
Incidence of new-onset diabetes after ADT
Time frame
From enrollment to 1-year after ADT2
Incidence of new-onset hypertension
Incidence of new-onset hypertension after ADT
Time frame
From enrollment to 1-year after ADT3
Changes in fasting blood sugar
Changes in fasting blood sugar (serum level)
Time frame
From enrollment to 1-year after ADT4
Changes in LDL-Cholesterol
Changes in LDL-Cholesterol (serum level)
Time frame
From enrollment to 1-year after ADTSponsors and contacts
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Source ClinicalTrials.gov