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Høy kardiovaskulær risikoinngripen med kardio-onkologisk konsultasjon for prostatakreft etter androgenreseptorvei-hemmer (ARPI) behandling (Heart-Safe)

1. oktober 2026 oppdatert av: Katelyn Atkins, Cedars-Sinai Medical Center

Høy kardiovaskulær risikobehandling med kardio-onkologisk konsultasjon for prostatakreft etter androgenreseptorveihemmer (ARPI) terapi (Hjerte-Sikker)

In patients with prostate cancer (PC), cardiovascular disease (CVD) causes significant morbidity and is the second leading cause of death. Both pre-existing CVD and the use of androgen deprivation therapy (ADT)-a key cornerstone of treatment for men with locally advanced or metastatic PC1,2 contribute to increased CV risk. ADT has been associated with adverse metabolic effects, including increased central adiposity, elevated low-density lipoprotein (LDL) levels, impaired glycemic control, and arterial wall remodeling and endothelial dysfunction

The data demonstrates that for most patients, the status quo is insufficient6 and there remains a critical gap in the early identification of high CV-risk PC patients who may benefit most from aggressive risk mitigation strategies. Mitigation strategies, like the addition of statins as primary prevention, have shown decrease in MI/CHD death across thousands of patients. Age-related expansion of hematopoietic clones carrying recurrent somatic mutations, termed clonal hematopoiesis of indeterminate potential (CHIP) has recently been identified as a significant driver of atherosclerosis, doubling the risk of coronary heart disease. Notably, while CHIP is detectable in ~10% of persons over 70 years old, it is enriched in patients with solid malignancies, and radiotherapy exposure is among the most decisive risk factors for developing CHIP12-15. The inflammation-related metabolic signals are activated androgen signaling and exacerbated in patients with CHIP. However, the mechanistic link and clinical consequence are less understood. Therefore, it is critical to study the CV impact of CHIP and metabolic perturbations in patients with PC treated with ARSI therapy.

We plan to address these critical gaps by testing our innovative hypothesis that early cardio-oncology intervention with aggressive guidelines-based CV optimization during ARPI therapy will reduce CV risk and that CHIP and metabolomics will help identify adverse metabolic remodeling to improve CV risk prediction.

Robust epidemiological and clinical trial data consistently demonstrate that patients with PC are poorly optimized from a CV risk modification perspective, and existing CV risk models do not perform well in patients with cancer. The data demonstrates that for most patients, the status quo is insufficient and there remains a critical gap in the early identification of high CV-risk PC patients who may benefit most from aggressive risk mitigation strategies.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • California
      • Los Angeles, California, Forente stater, 90048
        • Rekruttering
        • Cedars Sinai Medical Center
        • Hovedetterforsker:
          • Leslie Ballas, MD
        • Hovedetterforsker:
          • Katelyn Atkins, MD, PhD
        • Ta kontakt med:

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

45 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • Prostate cancer with localized, very-high risk, lymph-node positive, and/or metastatic (Stage IV) disease.

  • Being treated with ARPI therapy with intended duration ≥ 18 months.

  • Age > 65 years old and at least one CV risk factor, or age 45-65 years with at least two CV risk factors:

    • Hypertension
    • Hyperlipidemia
    • Diabetes mellitus
    • Family history of early CAD (male first-degree relative (father or brother) with CAD before age 55; female first-degree relative (mother or sister) with CAD before age 65)
    • Presence of coronary artery calcium (CAC) on chest CT imaging
  • ECOG 0-2

  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

  • Prior ARPI therapy exposure > 6 months duration.
  • Established care with cardio-oncologist (cardiologist with expertise in CV risks of cancer and cardiotoxic cancer therapies).

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cardo-Oncolody Referral

Referral to cardio-oncology for guidelines-based personalized cardio-oncology management

Referral to cardio-oncology for guidelines-based personalized cardio-oncology management

Aktiv komparator: PCP/General Cardiology Care

Notification to patient's primary care physician and/or general cardiologist and recommendation for CV risk optimization after initiation of ARPI therapy

Notification to patient's primary care physician and/or general cardiologist and recommendation for CV risk optimization after initiation of ARPI therapy

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of any CV medication Initiation and/or Change
Tidsramme: 3 Months Post-Intervention

To evaluate the rate of any CV medication initiation and/or change at 3-months following cardio-oncology consultation versus standard of care. Rate of any CV medication intervention at 3-months (Note: CV medication defined as: lipid-lowering, anti-hypertensive, anti-anginal, anti-platelet, anti-arrhythmic, heart failure medications)

3 Months Post-Intervention

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Rate of Compliance with CV Therapeutic Medication Intervention
Tidsramme: 6 and 12 Months Post Intervention

To determine the rate of compliance with CV therapeutic medication intervention at 6 and 12 months

6 and 12 Months Post Intervention
Rate of Statin Intervetion
Tidsramme: 3 Months Post Intervention

To determine the rate of statin intervention at 3 months

3 Months Post Intervention
Rate of Compliance with Statin Medication Intervention
Tidsramme: 6 and 12 Months Post Intervention

To determine the rate of compliance with statin medication intervention at 6 and 12 months

6 and 12 Months Post Intervention
Rate of any CV Medication Intervention
Tidsramme: 6 Months Post-Intervention

To determine the rate of any CV medication intervention at 6 months

6 Months Post-Intervention
Changes in Biological CV Risk Factor
Tidsramme: 3, 6, and 12 Month Post-Intervention

To assess changes in biological CV risk factors (low density lipoprotein [LDL])

3, 6, and 12 Month Post-Intervention
Changes in Biological CV Risk Factor
Tidsramme: 3, 6, and 12 Month Post-Intervention

To assess changes in biological CV risk factors (systolic blood pressure)

3, 6, and 12 Month Post-Intervention
Changes in Biological CV Risk Factor
Tidsramme: 3, 6, and 12 Month Post-Intervention

To assess changes in biological CV risk factors (hemoglobin A1c)

3, 6, and 12 Month Post-Intervention
Changes in Biological CV Risk Factor
Tidsramme: 3, 6, and 12 Month Post-Intervention

To assess changes in biological CV risk factors (body mass index)

3, 6, and 12 Month Post-Intervention
Rate of Coronary Artery Disease Testing
Tidsramme: 3, 6, and 12 Month Post-Intervention

To determine the rate of coronary artery disease (CAD) testing (coronary CT angiograms, CAC scans, stress tests, and invasive coronary angiograms)

3, 6, and 12 Month Post-Intervention
Rate of new CV or Cardiac Diagnosis
Tidsramme: 3, 6, and 12 Month Post-Intervention

To determine the rate of new CV or cardiac diagnosis

3, 6, and 12 Month Post-Intervention
One-Year MACE Rate
Tidsramme: 12 Months Post-Intervention

To determine the one-year MACE rate

12 Months Post-Intervention
Rate of Grade ≥ 2 Cardiac CTCAE
Tidsramme: 12 Month Post-Intervention

To determine one-year rate of grade ≥ 2 cardiac common terminology criteria for adverse events (CTCAE)

12 Month Post-Intervention

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Katelyn Atkins, MD, PhD, Cedars-Sinai Medical Center
  • Hovedetterforsker: Leslie Ballas, MD, Cedars-Sinai Medical Center

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)

15. juli 2026

Primær fullføring (Antatt)

1. august 2030

Studiet fullført (Antatt)

1. august 2030

Datoer for studieregistrering

Først innsendt

29. oktober 2025

Først innsendt som oppfylte QC-kriteriene

30. oktober 2025

Først lagt ut (Faktiske)

31. oktober 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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