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CURA CV: cura cardiovascolare nei pazienti con PC

18 settembre 2026 aggiornato da: Alicia Morgans, Dana-Farber Cancer Institute

CV CARE: cura cardiovascolare degli effetti correlati agli androgeni nei pazienti con cancro alla prostata

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)

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

180

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Reclutamento
        • Dana-Farber Cancer Institute
        • Contatto:
        • Investigatore principale:
          • Alicia Morgans, MD, MPH
      • Boston, Massachusetts, Stati Uniti, 02215
        • Reclutamento
        • Brigham and Women's Hospital
        • Contatto:
        • Investigatore principale:
          • Alicia Morgans, MD, MPH

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Sperimentale: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participant Retention Rate in CV CARE 2
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Participants on Statin Medications in CV CARE
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Dana-Farber Cancer Institute

Collaboratori

National Comprehensive Cancer Network

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 gennaio 2024

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

30 giugno 2027

Date di iscrizione allo studio

Primo inviato

1 gennaio 2024

Primo inviato che soddisfa i criteri di controllo qualità

1 gennaio 2024

Primo Inserito (Effettivo)

12 gennaio 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 23-311

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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