Intervention à haut risque cardiovasculaire avec consultation cardio-oncologique pour le cancer de la prostate suite au traitement par inhibiteur de la voie des récepteurs aux androgènes (ARPI) (Heart-Safe)
Intervention à haut risque cardiovasculaire avec consultation cardio-oncologique pour le cancer de la prostate suite à un traitement par inhibiteur de la voie des récepteurs aux androgènes (ARPI) (Heart-Safe)
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.
Aperçu de l'étude
Statut
Statut
Les conditions
Les conditions
Intervention / Traitement
Intervention / Traitement
Type d'étude
Type d'étude
Inscription (Estimé)
Inscription
Phase
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
Coordonnées de l'étude
- Nom: Clinical Trial Recruitment Navigator
- Numéro de téléphone: 310-423-5842
- E-mail: GroupCancerTrialInformation@cshs.org
Sauvegarde des contacts de l'étude
- Nom: Katelyn Atkins, MD, PhD
- E-mail: katelyn.atkins@csmc.edu
Lieux d'étude
-
-
California
-
Los Angeles, California, États-Unis, 90048
- Recrutement
- Cedars Sinai Medical Center
-
Chercheur principal:
- Leslie Ballas, MD
-
Chercheur principal:
- Katelyn Atkins, MD, PhD
-
Contact:
- Clinical Trial Recruitment Navigator
- Numéro de téléphone: 13104232133
- E-mail: GroupCancerTrialInformation@cshs.org
-
-
Critères de participation
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Nombre de bras
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Comparateur actif: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of any CV medication Initiation and/or Change
Délai: 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
|
Mesures de résultats secondaires
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The Rate of Compliance with CV Therapeutic Medication Intervention
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 12 Months Post-Intervention
|
To determine the one-year MACE rate |
12 Months Post-Intervention
|
|
Rate of Grade ≥ 2 Cardiac CTCAE
Délai: 12 Month Post-Intervention
|
To determine one-year rate of grade ≥ 2 cardiac common terminology criteria for adverse events (CTCAE) |
12 Month Post-Intervention
|
Collaborateurs et enquêteurs
Parrainer
Parrainer
Les enquêteurs
Les enquêteurs
- Chercheur principal: Katelyn Atkins, MD, PhD, Cedars-Sinai Medical Center
- Chercheur principal: Leslie Ballas, MD, Cedars-Sinai Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Début de l'étude
Achèvement primaire (Estimé)
Achèvement primaire
Achèvement de l'étude (Estimé)
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Première publication
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour publiée
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Processus pathologiques
- Tumeurs génitales, homme
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies génitales, sexe masculin
- Maladies de la prostate
- Maladies urogénitales masculines
- Conditions pathologiques, signes et symptômes
- Tumeurs prostatiques
- Maladie
Autres numéros d'identification d'étude
Autres numéros d'identification d'étude
- IIT2025-09-BALLAS-ATKINS-HEART
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .