Cardiovascular Care for Prostate Cancer

Recruiting at 1 trial location

Overseen By Alicia Morgans, MD, MPH

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: Androgen deprivation therapy

Must not be taking: Chemotherapy, Radioligand therapy

Disqualifiers: Recent cardiac event, Long ADT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to manage heart health risks in people with prostate cancer who are starting hormone therapy (androgen deprivation therapy or ADT). The researchers aim to determine if a standardized method can be implemented in clinics to enhance heart health care while treating prostate cancer. Participants will receive heart health education during their regular cancer care visits. This trial suits those with prostate cancer who are about to begin or have recently started hormone therapy and are willing to attend specific follow-up visits and assessments. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve heart health management for future patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants can continue certain treatments like androgen receptor signaling inhibitors, immunotherapy, or PARP inhibitors. It's best to discuss your specific medications with the trial team.

What prior data suggests that the CV Care Program is safe for participants with prostate cancer?

Research has shown that the CV Care Program, designed to monitor and manage heart health, is safe for participants. This program targets prostate cancer patients undergoing androgen deprivation therapy (ADT) and aims to identify and manage heart-related risks. Experts recommend such programs to help reduce heart health risks.

The CV Care Program includes regular check-ups and educational sessions to help patients maintain their heart health. This approach aims to improve overall health without introducing new medications or treatments that could be harmful.

So far, studies have not identified any major side effects directly linked to the CV Care Program, suggesting it is well-tolerated by participants. The program primarily offers guidance and monitoring, helping to keep participants safe while focusing on improving heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CV Care Program because it aims to enhance cardiovascular health in prostate cancer patients undergoing androgen deprivation therapy (ADT). Unlike typical treatments that focus solely on cancer management, this program integrates cardiovascular care into standard cancer treatment. The program includes educational modules, regular follow-ups, and exit interviews, which allow for continuous feedback and improvement. By addressing cardiovascular health alongside cancer treatment, the program could improve overall patient outcomes and quality of life.

What evidence suggests that the CV Care Program is effective for managing cardiovascular risk in prostate cancer patients?

Research shows that men with prostate cancer who begin hormone therapy, known as androgen deprivation therapy (ADT), must manage their heart health. Studies indicate that these men are more likely to experience heart problems, with two-thirds at high risk. In this trial, participants will join one of two versions of the CV Care Program, which checks and manages these heart risks. For instance, one study found that 99% of prostate cancer patients have at least one poorly managed heart risk factor. This program aims to improve heart health by addressing these issues early. ^{1 2 4 5 6}

Who Is on the Research Team?

Alicia Morgans, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for individuals with prostate cancer who are beginning androgen deprivation therapy (ADT). It aims to help manage cardiovascular risks that may arise from their cancer treatment. Participants should be starting ADT soon or have started it recently.

Inclusion Criteria

I am willing to have lab tests and check my blood pressure at home for virtual follow-ups.

I am on a treatment plan that includes at least 24 weeks of ADT, and I may have already started up to 12 weeks of it.

Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

I have not been on ADT therapy for prostate cancer for more than 12 weeks.

I am not on ADT with chemotherapy, radioligand therapy, or any clinical trial treatments.

Participants actively included in therapeutic clinical trials are not eligible due to their greater time constraints.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care androgen deprivation therapy and participate in the CV Care program

24 weeks

4 visits (in-person) at weeks 4, 12, and 24

Follow-up

Participants are monitored for safety and effectiveness after treatment, including feedback collection through surveys and interviews

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CV Care Program

Trial Overview The study is testing a 'CV Care Program' designed to assess and manage heart health risks in patients undergoing ADT for prostate cancer. The goal is to see if this program can become a standard part of patient care at the Dana-Farber Cancer Institute.

How Is the Trial Designed?

Group I: CV Care Program 2 Experimental Treatment 1 Intervention

Study procedures will be conducted as follows: * Standard of care androgen deprivation therapy. * 4 week standard-of-care follow up visit in clinic with CV care education module completion. * 12-week standard-of-care prostate cancer care visit with oncologist. * 24-week standard-of-care post-ADT visit in clinic with CV Care module completion, surveys, and exit interview with clinical team members. * Participant feedback from surveys, exit-interviews, and possibly focus groups will be collected.

Group II: CV Care Program Experimental Treatment 1 Intervention

Study procedures will be conducted as follows: * Standard of care androgen deprivation therapy. * 4 week standard-of-care follow up visit in clinic with CV care education module completion. * 12-week standard-of-care prostate cancer care visit with oncologist. * 24-week standard-of-care post-ADT visit in clinic with CV Care module completion, surveys, and exit interview with clinical team members. * The CV Care program will be revised through participant feedback from assessments, surveys, focus groups, and exit-interviews. The revised CV Care Program will be used in the next cohort.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Comprehensive Cancer Network

Collaborator

Trials

121

Recruited

7,400+

Published Research Related to This Trial

Androgen deprivation therapy, particularly with GnRH agonists and maximal androgen blockade (MAB), is linked to an increased risk of cardiovascular disease (CVD), especially in patients with pre-existing CVD.

In contrast, GnRH antagonists, such as the novel agent abiraterone, do not show the same association with increased CVD risk, suggesting they may be safer options for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Effects of Androgen Deprivation Therapy in Prostate Cancer. Agarwal, M., Canan, T., Glover, G., et al.[2020]

In a study of 76,600 prostate cancer patients, those undergoing endocrine treatment (ET) showed the highest relative risk for cardiovascular disease (CVD), particularly ischemic heart disease and myocardial infarction, compared to those receiving curative treatment or surveillance.

Despite the increased risk of CVD associated with ET, the absolute risk differences were relatively small, suggesting that while CVD risk should be considered in treatment decisions, it should not prevent the use of ET when significant benefits are expected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absolute and relative risk of cardiovascular disease in men with prostate cancer: results from the Population-Based PCBaSe Sweden. Van Hemelrijck, M., Garmo, H., Holmberg, L., et al.[2022]

In a study of 9596 patients aged 65 and older with metastatic prostate cancer receiving androgen deprivation therapy (ADT), 31.8% had preexisting cardiovascular (CV) disease, highlighting a significant baseline morbidity in this population.

The 5-year cardiovascular mortality rates were notably high at 9.8% overall and 14.8% for those with preexisting CV disease, indicating that existing cardiovascular conditions are a major risk factor for mortality in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular mortality in patients with metastatic prostate cancer exposed to androgen deprivation therapy: a population-based study. Gandaglia, G., Sun, M., Popa, I., et al.[2015]

Hormonal therapies for prostate cancer, such as androgen deprivation therapy (ADT), can lead to cardiovascular toxicity and worsen existing cardiovascular risk factors, which is a significant concern since many patients already have poorly controlled cardiovascular issues.

To improve outcomes for prostate cancer patients undergoing therapy, it is essential to screen and manage cardiovascular risk factors proactively, and a multidisciplinary approach is recommended to tailor treatment based on individual cardiovascular risk profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approaches to Prevent and Manage Cardiovascular Disease in Patients Receiving Therapy for Prostate Cancer. Ng, CT., Bonilla, HMG., Bryce, AH., et al.[2023]

Among 90,494 veterans with prostate cancer, only 68.1% received comprehensive cardiovascular risk factor (CVRF) assessments, indicating a significant gap in care for this population.

Despite the known cardiovascular risks associated with androgen deprivation therapy (ADT), initiating ADT did not lead to substantial improvements in the assessment or management of CVRFs, highlighting the need for better interventions to address these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment and Management of Cardiovascular Risk Factors Among US Veterans With Prostate Cancer. Sun, L., Parikh, RB., Hubbard, RA., et al.[2022]

In a study of 340,806 patients with localized prostate cancer, cardiovascular disease (CVD) was found to be the leading cause of death, surpassing prostate cancer mortality shortly after diagnosis in low- and intermediate-risk groups.

Patients with localized prostate cancer have a significantly higher risk of CVD-related death compared to the general population, with the risk increasing over time, indicating the need for careful management of both prostate cancer and cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular mortality by cancer risk stratification in patients with localized prostate cancer: a SEER-based study. Luo, Z., Chi, K., Zhao, H., et al.[2023]

A study involving 209 prostate cancer patients on androgen deprivation therapy (ADT) found that cardiovascular risk (CVR) charts, such as the Framingham and ATP III scores, did not show significant changes in risk over 12 months, indicating they may not effectively identify the increased cardiovascular risk associated with ADT.

Despite the patients' average age of 73.8 years and various health measures taken, the CVR scores remained stable, suggesting that current CVR assessment tools may not adequately account for the risks posed by ADT in prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prostate cancer, antiandrogen treatment and cardiovascular risk]. Reinoso Hermida, S., Díaz Grávalos, GJ., Robles Castiñeiras, A., et al.[2021]

Cardiovascular disease (CVD) is the leading cause of death among men, including those with urologic cancers like prostate cancer, highlighting the importance of assessing cardiac risk factors in these patients.

Understanding and monitoring cardiovascular risk markers may not only help reduce the risk of CVD but could also potentially improve outcomes for certain urologic cancers, suggesting a significant overlap between cardiovascular health and cancer prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving overall men's health and potentially reducing the risk of certain cancers via serum markers and risk assessment for coronary heart disease. Moyad, MA.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10940372/

recommendations from the APMA PCCV expert network In summary, this article provides insights and guidance to improve management for patients with PCa undergoing ADT. Keywords: Cardiovascular ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7905496/

Assessment and Management of Cardiovascular Risk ... Are cardiovascular risk factors assessed and appropriately managed in patients with prostate cancer initiating androgen deprivation therapy?

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.35285

A practical guide for assessing and managing cardiovascular ... Data from the RADICAL PC study showed that two thirds of men with prostate cancer are at high CV risk: 99% of patients have at least one poorly ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06064149

Study Details | NCT06064149 | The CArdiovascular Risk ... The overarching goal of this trial is to develop mechanisms to improve cardiovascular care among such prostate cancer patients receiving ADT by increasing ...

5. jacc.org jacc.org/doi/10.1016/j.jaccao.2024.09.012

Cardiovascular Risk in Prostate Cancer In a retrospective analysis of patients with localized PC, ADT was associated with an approximately 2-fold higher risk for cardiovascular death in men ≥65 years ...

6. dana-farber.org dana-farber.org/clinical-trials/23-311

CV CARE: CardioVascular Care of Androgen Related ... This research is being done to test a program to assess and manage reversible cardiovascular (CV) risk factors in participants with prostate cancer starting ...