Prostate CancerNCT06202820
CV CARE: CardioVascular Care in PC Patients
A study testing CV Care Program in people with Prostate Cancer and Cardiovascular Diseases, run by Dana-Farber Cancer Institute at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Cardiovascular Diseases
- What is being tested?
- CV Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jan 2024to 30 Jun 2027
- Phase
- Interventional
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Alicia Morgans, MD, MPH, 857-215-1605, aliciak_morgans@dfci.harvard.edu
Alicia Morgans, MD, MPH
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Alicia Morgans, MD, MPH, 857-215-1605, aliciak_morgans@dfci.harvard.edu
Alicia Morgans, MD, MPH
About this study
Official title: CV CARE: CardioVascular Care of Androgen Related Effects in Prostate Cancer Patients
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)
Read the detailed 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.
- Conditions
- Prostate Cancer, Cardiovascular Diseases
- Being tested
- CV Care Program
- Keywords
- Prostate Cancer, Cardiovascular Diseases, Cardiovascular Risk
- Medical subject headings
- Prostatic Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CV Care ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CV Care Program | Experimental | 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. Receives: Behavioral: CV Care Program |
| CV Care Program 2 | Experimental | 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. Receives: Behavioral: CV Care Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Weeks 4 and 24 in CV CARE 2
Secondary outcomes (6)
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.
Measured: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
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.
Measured: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
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.
Measured: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
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.
Measured: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
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.
Measured: 6 months (From the ADT initiation to the week 24 on-treatment visit)
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.
Measured: 6 months (From the ADT initiation to the week 24 on-treatment visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start18 Jan 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Principal investigator, Alicia Morgans, Dana-Farber Cancer Institute
- Investigators
- Alicia Morgans, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202820
- Sponsor's protocol ID
- 23-311
- Status last verified
- Sep 2026
- First submitted
- 1 Jan 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CV CARE: CardioVascular Care of Androgen Related Effects in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT06202820
- Acronym / sponsor ID
- 23-311
- Conditions
- Prostate Cancer, Cardiovascular Diseases
- Keywords
- Prostate Cancer, Cardiovascular Diseases, Cardiovascular Risk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Jan 2024 (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.
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)
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CV Care Program | Experimental | Behavioral: CV Care ProgramStudy 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. |
| CV Care Program 2 | Experimental | Behavioral: CV Care ProgramStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CV Care ProgramComprised 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. | Behavioural | CV Care Program, CV Care Program 2 |
Primary outcome
Participant Retention Rate in CV CARE 2
Time frame: Weeks 4 and 24 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).
6 secondary outcomes
Proportion of Participants on Statin Medications in CV CARE
Time frame: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
Proportion of Participants on Statin Medications in CV CARE 2
Time frame: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
Proportion of Participants on Blood Pressure Medications in CV CARE
Time frame: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
Proportion of Participants on Blood Pressure Medications in CV CARE 2
Time frame: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
Proportion of Participants with Blood Pressure Below 130/85 (mmHg) in CV CARE
Time frame: 6 months (From the ADT initiation to the week 24 on-treatment visit)
Proportion of Participants with Blood Pressure Below 130/85 (mmHg) in CV CARE 2
Time frame: 6 months (From the ADT initiation to the week 24 on-treatment visit)
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 22 Sep 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Alicia Morgans, MD, MPH principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CV Care Program in people with Prostate Cancer and Cardiovascular Diseases, run by Dana-Farber Cancer Institute at 2 sites in United States.
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 10 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Alicia Morgans, MD, MPH (857-215-1605, aliciak_morgans@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Retention Rate in CV CARE 2 (time frame: Weeks 4 and 24 in CV CARE 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.