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

Overview

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 \& 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.

Primary outcome measures

• The change in Framingham Risk Score between baseline and 1-year after ADT. [Time frame: From enrollment to 1-year after ADT]

Secondary outcome measures (10)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Hong Kong · 1 center

• The Chinese University of Hong Kong — Hong Kong

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. PMID 18212285
• Ghadessi 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. PMID 32164754
• 21. 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. PMID 35312383
• Lopes 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 1 PMID 34459214
• Narayan 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. PMID 34988484
• Leong 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. PMID 36875915
• Lyon 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. PMID 36017568

Identifiers

NCT: NCT06163924 · CRE-2023.509

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗