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CV CARE: Kardiovaskulær omsorg hos PC-pasienter

18. september 2026 oppdatert av: Alicia Morgans, Dana-Farber Cancer Institute

CV CARE: Kardiovaskulær behandling av androgenrelaterte effekter hos prostatakreftpasienter

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)

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

180

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Rekruttering
        • Dana-Farber Cancer Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alicia Morgans, MD, MPH
      • Boston, Massachusetts, Forente stater, 02215
        • Rekruttering
        • Brigham and Women's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alicia Morgans, MD, MPH

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: CV Care Program

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.
Atferdsmessig: 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.
Eksperimentell: CV Care Program 2

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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Participant Retention Rate in CV CARE 2
Tidsramme: 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).
Weeks 4 and 24 in CV CARE 2

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants on Statin Medications in CV CARE
Tidsramme: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

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)
Proportion of Participants on Statin Medications in CV CARE 2
Tidsramme: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

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)
Proportion of Participants on Blood Pressure Medications in CV CARE
Tidsramme: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

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)
Proportion of Participants on Blood Pressure Medications in CV CARE 2
Tidsramme: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

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)
Proportion of Participants with Blood Pressure Below 130/85 (mmHg) in CV CARE
Tidsramme: 6 months (From the ADT initiation to the week 24 on-treatment visit)

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)
Proportion of Participants with Blood Pressure Below 130/85 (mmHg) in CV CARE 2
Tidsramme: 6 months (From the ADT initiation to the week 24 on-treatment visit)

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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Dana-Farber Cancer Institute

Samarbeidspartnere

National Comprehensive Cancer Network

Etterforskere

  • Hovedetterforsker: Alicia Morgans, MD, MPH, Dana-Farber Cancer Institute

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

18. januar 2024

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

1. januar 2024

Først innsendt som oppfylte QC-kriteriene

1. januar 2024

Først lagt ut (Faktiske)

12. januar 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 23-311

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Data can be shared no earlier than 1 year following the date of publication

Tilgangskriterier for IPD-deling

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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