Cardiovascular Care for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byAlicia Morgans, MD, MPH
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
Trial Summary
What is the purpose of this trial?This research is being done to test a program to assess and manage reversible cardiovascular (CV) risk factors in participants with prostate cancer starting androgen deprivation therapy (ADT), with the goal of integrating a standardized method into Dana-Farber Cancer Institute clinics for all such participants.
The name of the intervention used in this research study is:
CV Care (cardiovascular risk assessment and management program)
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 data supports the effectiveness of the Cardiovascular Care Program for prostate cancer patients?
Research suggests that managing cardiovascular risk factors can be crucial for prostate cancer patients, as cardiovascular disease is a leading cause of death in this group. By assessing and managing these risks, the Cardiovascular Care Program may help reduce the likelihood of heart-related issues, which are common in patients undergoing prostate cancer treatment.
12345Is the Cardiovascular Care Program safe for humans?
The safety data for the Cardiovascular Care Program, also known as the Cardiovascular Risk Assessment and Management Program, is not directly available. However, the research highlights the importance of managing cardiovascular risks in prostate cancer treatments, suggesting that careful monitoring is crucial to ensure safety.
13678How does this treatment differ from other prostate cancer treatments?
This treatment is unique because it focuses on managing cardiovascular health in patients with prostate cancer, which is important since prostate cancer therapies can increase the risk of heart disease. It emphasizes the importance of monitoring cardiovascular risk factors alongside cancer treatment to potentially improve overall health outcomes.
12357Eligibility Criteria
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.
+7 more
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.
+1 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: CV Care Program 2Experimental Treatment1 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 ProgramExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
Dana-Farber Cancer InstituteBoston, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor
National Comprehensive Cancer NetworkCollaborator
References
Approaches to Prevent and Manage Cardiovascular Disease in Patients Receiving Therapy for Prostate Cancer. [2023]Prostate cancer (PCa) is amongst the most common cancers in men worldwide. Cardiovascular (CV) risk factors and CV disease (CVD) are common comorbidities in this patient population, posing a challenge for PCa-directed therapies which can cause or worsen CVRFs and CVDs. Herein, we summarize the approaches to prevent and manage CVD in patients with PCa receiving therapy.
Improving overall men's health and potentially reducing the risk of certain cancers via serum markers and risk assessment for coronary heart disease. [2015]Introducing men to standard and other risk markers for cardiovascular disease (CVD) can be difficult, but especially in urologic oncology where men are being evaluated for non-cardiovascular conditions. The current explanations for discussing cardiac risk factors and assessment in potential urologic oncology patients include: (1) The primary cause of death of men in the U.S. and in most regions around the world is CVD; (2) the number 1 cause of death from the largest cancer prevention trials (high or average risk) is CVD; (3) the number 1 or 2 cause of death in men with prostate cancer is CVD; (4) a relationship between some factors that increase the risk of coronary heart disease (CHD) and similar factors that increase the risk of prostate cancer should not be ignored; (5) reducing the risk of CVD via cholesterol reduction may reduce the risk of certain urologic cancers such as prostate cancer and renal cell carcinoma; and (6) one of the potentially best methods to monitor the success of lifestyle changes for the patient in urologic oncology is to monitor cardiovascular markers, as is the case in some studies of men at higher risk or diagnosed with prostate cancer. Patients and clinicians need to know their cardiovascular risk markers as well as they know the results of their cancer screening tests because there is a potentially profound overlap between the 2 conditions. A better knowledge of these basic markers and risk assessment methods may not only reduce cardiovascular risk in the worst case scenario, but in the best case scenario could reduce the risk or improve the prognosis of certain types of cancer.
Cardiovascular Effects of Androgen Deprivation Therapy in Prostate Cancer. [2020]This review paper is a comprehensive look at the cardiovascular disease (CVD) risk that is associated with the use of androgen deprivation therapy in prostate cancer. It summarizes when certain cancer therapies are indicated and should guide physicians in identifying patients at increased risk for CVD during prostate cancer therapy.
Cardiovascular mortality by cancer risk stratification in patients with localized prostate cancer: a SEER-based study. [2023]The risk of cardiovascular disease (CVD) mortality in patients with localized prostate cancer (PCa) by risk stratification remains unclear. The aim of this study was to determine the risk of CVD death in patients with localized PCa by risk stratification.
Assessment and Management of Cardiovascular Risk Factors Among US Veterans With Prostate Cancer. [2022]Cardiovascular disease is a leading cause of mortality in patients with prostate cancer, and androgen deprivation therapy (ADT) may worsen cardiovascular risk. Adherence to guideline-recommended assessment and management of cardiovascular risk factors (CVRFs) in patients initiating ADT is unknown.
Absolute and relative risk of cardiovascular disease in men with prostate cancer: results from the Population-Based PCBaSe Sweden. [2022]Cardiovascular disease (CVD) is a potential adverse effect of endocrine treatment (ET) for prostate cancer (PC). We investigated absolute and relative CVD risk in 76,600 patients with PC undergoing ET, curative treatment, or surveillance.
[Prostate cancer, antiandrogen treatment and cardiovascular risk]. [2021]To assess if cardiovascular risk (CVR) charts are able to identify the increased risk caused by androgen deprivation therapy (ADT) in patients with prostate cancer (PCa).
Cardiovascular mortality in patients with metastatic prostate cancer exposed to androgen deprivation therapy: a population-based study. [2015]The aim of our study was to reexamine the prevalence of baseline cardiovascular (CV) morbidity and the rates of CV mortality in a contemporary cohort of patients with prostate cancer (PCa) exposed to androgen deprivation therapy (ADT).