CV CARE: CardioVascular Care in PC Patients

Prostate Cancer Clinical Trial

Official title:

CV CARE: CardioVascular Care of Androgen Related Effects in Prostate Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06202820
• Other study ID #: 23-311
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Dana-Farber Cancer Institute
• Contact: Alicia Morgans, MD, MPH
• Phone: 857-215-1605
• Email: aliciak_morgans[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Description:

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. Study procedures including screening for eligibility, treatment visits, questionnaires and surveys, and blood and urine tests. Participation in this research study is expected to last about 6 months. It is expected that about 60-150 people will take part in this study. This study is supported by the National Comprehensive Cancer Network (NCCN) through grant funding provided by Pfizer Myovant.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 31, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must have a histologic diagnosis of prostate adenocarcinoma. Participants with any stage of prostate cancer are eligible, as long as treatment with at least 24 weeks of ADT is recommended by their treating physician.
• Participants must have been prescribed a plan for treatment with at least 24 weeks of ADT, and can have received up to 12 weeks of ADT therapy.
• Participants must be willing to participate in two CV CARE visits at weeks 12 and 24 after ADT initiation.
• Participants must be willing to have their follow up visits for ADT management at DFCI Longwood site.
• Participants must be willing to undergo lab and blood pressure assessments, which can include local labs and home blood pressure checks if they wish to do virtual visits for follow up care.
• Participants can have pre-existing CVD and/or CV risk factors, but this is not a requirement for inclusion.
• Participants receiving combination treatment with an androgen receptor signaling inhibitory, some examples being (abiraterone acetate, enzalutamide, darolutamide, apalutamide, or bicalutamide), immunotherapy (pembrolizumab), or PARP inhibitor (olaparib, rucaparib) are eligible.
• Age =18 years.
• Life expectancy of greater than 6 months.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 24 weeks due to complicated comorbidities that necessitate close collaboration between the participant and their cardiologist.
• Participants who have already been on ADT therapy for more than 12 weeks are ineligible due to their treatment cycle being incompatible with the quality improvement initiative's trial design. ADT therapy is defined as either a GnRH agonist or antagonist.
• Participants receiving combination treatment with ADT and chemotherapy (docetaxel, cabazitaxel, carboplatin), radioligand therapy (radium-223, 177PSMA-lutetium-617), or treatment on a clinical trial are not eligible due to potential for more intensive symptom management that may be required for optimal support of their cancer-directed treatment.
• Participants actively included in therapeutic clinical trials are not eligible due to their greater time constraints.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• CV Care Program
Comprised of two, in-clinic, counseling sessions with oncology nurse practitioner or physician assistant for education on cardiovascular disease (CVD) and cardiovascular risk factors as well as recommendations for management.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Retention Rate in CV CARE 2	The percentage of a continued participation rate at week 24 of participants who participate at week 4 in the revised iteration of the program (CV CARE 2).	Weeks 4 and 24 in CV CARE 2
Secondary	Proportion of Participants on Statin Medications in CV CARE	The percentage of participants who initiate or adjust statin medication usage during the period between 4 weeks after ADT initiation and the week 24 on-treatment visit among individuals with ASCVD risk scores exceeding 10% and 20% at week 4 of the study.	5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
Secondary	Proportion of Participants on Statin Medications in CV CARE 2	The percentage of participants who initiate or adjust statin medication usage during the period between 4 weeks after ADT initiation and the week 24 on-treatment visit among individuals with ASCVD risk scores exceeding 10% and 20% at week 4 of the study.	5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
Secondary	Proportion of Participants on Blood Pressure Medications in CV CARE	The percentage of participants who initiate or adjust blood pressure medication usage during the period between 4 weeks after ADT initiation and the week 24 on-treatment visit among individuals with ASCVD risk scores exceeding 10% and 20% at week 4 of the study.	5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
Secondary	Proportion of Participants on Blood Pressure Medications in CV CARE 2	The percentage of participants who initiate or adjust blood pressure medication usage during the period between 4 weeks after ADT initiation and the week 24 on-treatment visit among individuals with ASCVD risk scores exceeding 10% and 20% at week 4 of the study.	5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
Secondary	Proportion of Participants with Blood Pressure Below 130/85 (mmHg) in CV CARE	The comparison of proportion of participants with a blood pressure below 130/85 mmHg between the average blood pressure levels of weeks 12 and 24 of the program and the average blood pressure levels of ADT initiation and week 4.	6 months (From the ADT initiation to the week 24 on-treatment visit)
Secondary	Proportion of Participants with Blood Pressure Below 130/85 (mmHg) in CV CARE 2	The comparison of proportion of participants with a blood pressure below 130/85 mmHg between the average blood pressure levels of weeks 12 and 24 of the program and the average blood pressure levels of ADT initiation and week 4.	6 months (From the ADT initiation to the week 24 on-treatment visit)