Clinical trial NCT06163924: The Effect of Multidisciplinary Care Approach on CV Risk Modification in CaP Patients Receiving ADT
Official title: To Investigate the Effect of Multidisciplinary Care Approach on Cardiovascular Risk Modification in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Risk
Prostate Cancer
Keywords: Prostate Cancer
Androgen deprivation Therapy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: prostate cancer patients receiving androgen deprivation therapy

Brief summary: 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.

Detailed description: 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 \&amp;amp; 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 \&lt;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

Primary outcomes:
measure: The change in Framingham Risk Score between baseline and 1-year after ADT.
timeFrame: From enrollment to 1-year after ADT
Secondary outcomes:
measure: Incidence of new-onset diabetes
timeFrame: From enrollment to 1-year after ADT
measure: Incidence of new-onset hypertension
timeFrame: From enrollment to 1-year after ADT
measure: Changes in fasting blood sugar
timeFrame: From enrollment to 1-year after ADT
measure: Changes in LDL-Cholesterol
timeFrame: From enrollment to 1-year after ADT
measure: Changes in HDL-cholesterol
timeFrame: From enrollment to 1-year after ADT
measure: Changes in triglyceride
timeFrame: From enrollment to 1-year after ADT
measure: Changes in HbA1c
timeFrame: From enrollment to 1-year after ADT
measure: Incidence of additional medical therapies for optimization of cardiovascular risk
timeFrame: From enrollment to 1-year after ADT
measure: Change in pulse wave velocity
timeFrame: From enrollment to 1-year after ADT
measure: Change in Quality of life
timeFrame: From enrollment to 1-year after ADT
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
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