Cardiovascular RiskNCT06163924
The Effect of Multidisciplinary Care Approach on CV Risk Modification in CaP Patients Receiving ADT
An observational study of Cardiovascular Risk and Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Cardiovascular Risk, Prostate Cancer
- How many people
- 130 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Dec 2023to 31 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: prostate cancer patients receiving androgen deprivation therapy
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Sui Yan LAU, 852-3505-3933, beckylau@surgery.cuhk.edu.hk
CHI FAI NG, Professor
About this study
Official title: To Investigate the Effect of Multidisciplinary Care Approach on Cardiovascular Risk Modification in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
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.
Read the 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; 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.
- Conditions
- Cardiovascular Risk, Prostate Cancer
- Keywords
- Prostate Cancer, Androgen deprivation Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCa receiving ADT | prostate cancer patients receiving androgen deprivation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 1-year after ADT
Secondary outcomes (10)
Incidence of new-onset diabetes
Incidence of new-onset diabetes after ADT
Measured: From enrollment to 1-year after ADT
Incidence of new-onset hypertension
Incidence of new-onset hypertension after ADT
Measured: From enrollment to 1-year after ADT
Changes in fasting blood sugar
Changes in fasting blood sugar (serum level)
Measured: From enrollment to 1-year after ADT
Changes in LDL-Cholesterol
Changes in LDL-Cholesterol (serum level)
Measured: From enrollment to 1-year after ADT
Changes in HDL-cholesterol
Changes in HDL-cholesterol (serum level)
Measured: From enrollment to 1-year after ADT
Changes in triglyceride
Changes in triglyceride (serum level)
Measured: From enrollment to 1-year after ADT
Changes in HbA1c
Changes in HbA1c (serum level)
Measured: From enrollment to 1-year after ADT
Incidence of additional medical therapies for optimization of cardiovascular risk
Number of additional cardiovascular medical therapies
Measured: From enrollment to 1-year after ADT
Change in pulse wave velocity
Change in pulse wave velocity assessed by the Vascular Profiler-1000 machine (Omron, Kyoto, Japan) using the oscillometric cuff technique
Measured: From enrollment to 1-year after ADT
Change in Quality of life
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
Measured: From enrollment to 1-year after ADT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start10 Dec 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular RiskStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NG Chi Fai, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163924
- Sponsor's protocol ID
- CRE-2023.509
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.
PubMed 18212285Ghadessi M, Tang R, Zhou J, Liu R, Wang C, Toyoizumi K, Mei C, Zhang L, Deng CQ, Beckman RA. A roadmap to using historical controls in clinical trials - by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG). Orphanet J Rare Dis. 2020 Mar 12;15(1):69. doi: 10.1186/s13023-020-1332-x.
PubMed 3216475421. Ng CF, Wei Y, Ong TA, Chan W, Chu PSK, Huang CY, et al. The changes in metabolic profiles and cardiovascular risk in Asian prostate cancer patients after androgen deprivation therapy - a prospective real-life evaluation. Int J Urol 2020; 27 S1: UOP-1430.
Ng CF, Teoh JYC, Chiu PKF. Letter by Ng et al Regarding Article, "Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial". Circulation. 2022 Mar 22;145(12):e773-e774. doi: 10.1161/CIRCULATIONAHA.121.057407. Epub 2022 Mar 21. No abstract available.
PubMed 35312383Lopes RD, Higano CS, Slovin SF, Nelson AJ, Bigelow R, Sorensen PS, Melloni C, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Clarke NW, Olesen TK, Doyle-Olsen BT, Kristensen H, Arney L, Roe MT, Alexander JH; PRONOUNCE Study Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial. Circulation. 2021 Oct 19;144(16):1295-1307. doi: 10.1161/CIRCULATIONAHA.121.056810. Epub 2021 Aug 30.
PubMed 34459214Narayan V, Ross AE, Parikh RB, Nohria A, Morgans AK. How to Treat Prostate Cancer With Androgen Deprivation and Minimize Cardiovascular Risk: A Therapeutic Tightrope. JACC CardioOncol. 2021 Dec 21;3(5):737-741. doi: 10.1016/j.jaccao.2021.09.014. eCollection 2021 Dec.
PubMed 34988484Leong DP, Mukherjee SD. The European Society of Cardiology Cardio-Oncology Guidelines: Evidence Base, Actionability, and Relevance to Clinical Practice. JACC CardioOncol. 2022 Dec 6;5(1):137-140. doi: 10.1016/j.jaccao.2022.10.009. eCollection 2023 Feb. No abstract available.
PubMed 36875915Lyon 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. 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS). Eur Heart J. 2022 Nov 1;43(41):4229-4361. doi: 10.1093/eurheartj/ehac244. No abstract available.
PubMed 36017568Li JKM, Wang LL, Wong CYP, Chiu PKF, Teoh JYC, Kwok HSW, Leung SCH, Wong SH, Tsui SKW, Ng CF. A cross-sectional study on gut microbiota in prostate cancer patients with prostatectomy or androgen deprivation therapy. Prostate Cancer Prostatic Dis. 2021 Dec;24(4):1063-1072. doi: 10.1038/s41391-021-00360-1. Epub 2021 Apr 13.
PubMed 33850270Teoh JY, Tian XY, Wong CY, Lau CW, Cheng CK, Tang VW, Chan RC, Huang Y, Ng CF. Endothelial dysfunction after androgen deprivation therapy and the possible underlying mechanisms. Prostate. 2022 Jan;82(1):13-25. doi: 10.1002/pros.24244. Epub 2021 Sep 27.
PubMed 34570375Wong C, Chu P, Teoh J, Chiu P, Yee CH, Chau L, Chan M, Wan H, Leung S, Ng CF. Risks of metabolic diseases and androgen deprivation therapy for prostate cancer in a Chinese population: a prospective multi-centre cohort study. Int Urol Nephrol. 2022 May;54(5):993-1000. doi: 10.1007/s11255-022-03151-2. Epub 2022 Feb 25.
PubMed 35217907Ng CF, Chiu PKF, Yee CH, Lau BSY, Leung SCH, Teoh JYC. Effect of androgen deprivation therapy on cardiovascular function in Chinese patients with advanced prostate cancer: a prospective cohort study. Sci Rep. 2020 Oct 22;10(1):18060. doi: 10.1038/s41598-020-75139-w.
PubMed 33093594Chan JSK, Tang P, Hui JMH, Lee YHA, Dee EC, Ng K, Liu K, Tse G, Ng CF. Association between duration of gonadotrophin-releasing hormone agonist use and cardiovascular risks: A population-based competing-risk analysis. Prostate. 2022 Nov;82(15):1477-1480. doi: 10.1002/pros.24423. Epub 2022 Aug 1.
PubMed 35915869Teoh JY, Chiu PK, Chan SY, Poon DM, Cheung HY, Hou SS, Ng CF. Androgen deprivation therapy, diabetes and poor physical performance status increase fracture risk in Chinese men treated for prostate cancer. Aging Male. 2015;18(3):180-5. doi: 10.3109/13685538.2015.1046043. Epub 2015 May 25.
PubMed 26004988Teoh JY, Chiu PK, Chan SY, Poon DM, Cheung HY, Hou SS, Ng CF. Risk of new-onset diabetes after androgen deprivation therapy for prostate cancer in the Asian population. J Diabetes. 2015 Sep;7(5):672-80. doi: 10.1111/1753-0407.12226. Epub 2014 Dec 22.
PubMed 25266491
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Effect of Multidisciplinary Care Approach on Cardiovascular Risk Modification in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT06163924
- Acronym / sponsor ID
- CRE-2023.509
- Conditions
- Cardiovascular Risk, Prostate Cancer
- Keywords
- Prostate Cancer, Androgen deprivation Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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; 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCa receiving ADT | – | –prostate cancer patients receiving androgen deprivation therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- prostate cancer patients receiving androgen deprivation therapy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
Incidence of new-onset diabetes
Time frame: From enrollment to 1-year after ADT
Incidence of new-onset hypertension
Time frame: From enrollment to 1-year after ADT
Changes in fasting blood sugar
Time frame: From enrollment to 1-year after ADT
Changes in LDL-Cholesterol
Time frame: From enrollment to 1-year after ADT
Changes in HDL-cholesterol
Time frame: From enrollment to 1-year after ADT
Changes in triglyceride
Time frame: From enrollment to 1-year after ADT
Changes in HbA1c
Time frame: From enrollment to 1-year after ADT
Incidence of additional medical therapies for optimization of cardiovascular risk
Time frame: From enrollment to 1-year after ADT
Change in pulse wave velocity
Time frame: From enrollment to 1-year after ADT
Change in Quality of life
Time frame: From enrollment to 1-year after ADT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 18212285D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.
- Background: PubMed 32164754Ghadessi M, Tang R, Zhou J, Liu R, Wang C, Toyoizumi K, Mei C, Zhang L, Deng CQ, Beckman RA. A roadmap to using historical controls in clinical trials - by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG). Orphanet J Rare Dis. 2020 Mar 12;15(1):69. doi: 10.1186/s13023-020-1332-x.
- Background21. Ng CF, Wei Y, Ong TA, Chan W, Chu PSK, Huang CY, et al. The changes in metabolic profiles and cardiovascular risk in Asian prostate cancer patients after androgen deprivation therapy - a prospective real-life evaluation. Int J Urol 2020; 27 S1: UOP-1430.
- Background: PubMed 35312383Ng CF, Teoh JYC, Chiu PKF. Letter by Ng et al Regarding Article, "Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial". Circulation. 2022 Mar 22;145(12):e773-e774. doi: 10.1161/CIRCULATIONAHA.121.057407. Epub 2022 Mar 21. No abstract available.
- Background: PubMed 34459214Lopes RD, Higano CS, Slovin SF, Nelson AJ, Bigelow R, Sorensen PS, Melloni C, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Clarke NW, Olesen TK, Doyle-Olsen BT, Kristensen H, Arney L, Roe MT, Alexander JH; PRONOUNCE Study Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial. Circulation. 2021 Oct 19;144(16):1295-1307. doi: 10.1161/CIRCULATIONAHA.121.056810. Epub 2021 Aug 30.
- Background: PubMed 34988484Narayan V, Ross AE, Parikh RB, Nohria A, Morgans AK. How to Treat Prostate Cancer With Androgen Deprivation and Minimize Cardiovascular Risk: A Therapeutic Tightrope. JACC CardioOncol. 2021 Dec 21;3(5):737-741. doi: 10.1016/j.jaccao.2021.09.014. eCollection 2021 Dec.
- Background: PubMed 36875915Leong DP, Mukherjee SD. The European Society of Cardiology Cardio-Oncology Guidelines: Evidence Base, Actionability, and Relevance to Clinical Practice. JACC CardioOncol. 2022 Dec 6;5(1):137-140. doi: 10.1016/j.jaccao.2022.10.009. eCollection 2023 Feb. No abstract available.
- Background: PubMed 36017568Lyon 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. 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS). Eur Heart J. 2022 Nov 1;43(41):4229-4361. doi: 10.1093/eurheartj/ehac244. No abstract available.
- Background: PubMed 33850270Li JKM, Wang LL, Wong CYP, Chiu PKF, Teoh JYC, Kwok HSW, Leung SCH, Wong SH, Tsui SKW, Ng CF. A cross-sectional study on gut microbiota in prostate cancer patients with prostatectomy or androgen deprivation therapy. Prostate Cancer Prostatic Dis. 2021 Dec;24(4):1063-1072. doi: 10.1038/s41391-021-00360-1. Epub 2021 Apr 13.
- Background: PubMed 34570375Teoh JY, Tian XY, Wong CY, Lau CW, Cheng CK, Tang VW, Chan RC, Huang Y, Ng CF. Endothelial dysfunction after androgen deprivation therapy and the possible underlying mechanisms. Prostate. 2022 Jan;82(1):13-25. doi: 10.1002/pros.24244. Epub 2021 Sep 27.
- Background: PubMed 35217907Wong C, Chu P, Teoh J, Chiu P, Yee CH, Chau L, Chan M, Wan H, Leung S, Ng CF. Risks of metabolic diseases and androgen deprivation therapy for prostate cancer in a Chinese population: a prospective multi-centre cohort study. Int Urol Nephrol. 2022 May;54(5):993-1000. doi: 10.1007/s11255-022-03151-2. Epub 2022 Feb 25.
- Background: PubMed 33093594Ng CF, Chiu PKF, Yee CH, Lau BSY, Leung SCH, Teoh JYC. Effect of androgen deprivation therapy on cardiovascular function in Chinese patients with advanced prostate cancer: a prospective cohort study. Sci Rep. 2020 Oct 22;10(1):18060. doi: 10.1038/s41598-020-75139-w.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiovascular Risk
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Active, not recruiting
Dietary Behavior Intervention in African Americans at Risk for Cardiovascular Disease
Diet, Cooking
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
RecruitingPhase 2
Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)
Arrhythmogenic Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk and Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi Fai NG, Professor (852-3505-3933, ngcf@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Framingham Risk Score between baseline and 1-year after ADT. (time frame: From enrollment to 1-year after ADT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06163924, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.