RightFit
RecruitingNot applicable

CV CARE: CardioVascular Care in PC Patients

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Urine samples, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study procedures including screening for eligibility, treatment visits, questionnaires and surveys, and blood and urine tests."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CV Care, a program to check and manage heart and blood vessel risks that can be improved. It is for adults with prostate cancer who are starting androgen deprivation therapy (ADT), a treatment that lowers male hormones.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and expected to live more than 6 months.
  • Have prostate adenocarcinoma confirmed by a tissue test. Cancer at any stage is allowed.
  • Have a doctor's plan for at least 24 weeks of ADT and have received no more than 12 weeks so far.
  • Be willing to attend two CV Care visits, at 12 and 24 weeks after starting ADT.
  • Be willing to have ADT follow-up care at Dana-Farber Cancer Institute's Longwood site.
  • Be willing to have lab tests and blood pressure checks. For virtual follow-up visits, local labs and home blood pressure checks are allowed.
  • You may join with or without existing heart or blood vessel disease or risk factors. Certain added hormone-blocking, immune-based, or PARP-blocking cancer drugs are allowed.
  • Be able to understand the study and willing to sign a consent form.

Who can't join

  • Had a heart attack, stroke, or new or worsening heart failure in the past 24 weeks, with complex health problems needing close care from a heart doctor. Heart failure means the heart does not pump well.
  • Have already received more than 12 weeks of ADT with a GnRH agonist or antagonist, drugs that lower male hormones.
  • Are receiving ADT with chemotherapy, targeted radiation drugs called radioligand therapy, or treatment in a clinical trial.
  • Are currently taking part in a clinical trial that tests a treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

MA