Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06163924

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

The Chinese University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

CHI FAI NG, Professor

PRINCIPAL_INVESTIGATOR

Sui Yan LAU

CONTACT

[email protected]

852-3505-3933

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The change in Framingham Risk Score between baseline and 1-year after ADT.

    Time frame: 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.

Secondary outcomes

  1. Incidence of new-onset diabetes

    Time frame: From enrollment to 1-year after ADT

    Incidence of new-onset diabetes after ADT

  2. Incidence of new-onset hypertension

    Time frame: From enrollment to 1-year after ADT

    Incidence of new-onset hypertension after ADT

  3. Changes in fasting blood sugar

    Time frame: From enrollment to 1-year after ADT

    Changes in fasting blood sugar (serum level)

  4. Changes in LDL-Cholesterol

    Time frame: From enrollment to 1-year after ADT

    Changes in LDL-Cholesterol (serum level)

  5. Changes in HDL-cholesterol

    Time frame: From enrollment to 1-year after ADT

    Changes in HDL-cholesterol (serum level)

  6. Changes in triglyceride

    Time frame: From enrollment to 1-year after ADT

    Changes in triglyceride (serum level)

  7. Changes in HbA1c

    Time frame: From enrollment to 1-year after ADT

    Changes in HbA1c (serum level)

  8. Incidence of additional medical therapies for optimization of cardiovascular risk

    Time frame: From enrollment to 1-year after ADT

    Number of additional cardiovascular medical therapies

  9. Change in pulse wave velocity

    Time frame: From enrollment to 1-year after ADT

    Change in pulse wave velocity assessed by the Vascular Profiler-1000 machine (Omron, Kyoto, Japan) using the oscillometric cuff technique

  10. Change in Quality of life

    Time frame: From enrollment to 1-year after ADT

    EQ-5D (EuroQol 5 dimensions) questionnaire Quality of life measured by ED-5Q questionnaire, with 5 components [Mobility, Self Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression)], and a Visual analogue scale from 0 to 100 (EQ-VAS) score, the higher the score the better in quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Chi Fai NG, Professor

CONTACT

[email protected]

852-3505-3933

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Dec 11, 2023
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.