高心血管リスク介入:アンドロゲン受容体経路阻害薬(ARPI)療法後の前立腺がんに対する心臓腫瘍学相談を伴う(Heart-Safe)
高心血管リスク介入:アンドロゲン受容体経路阻害剤(ARPI)療法後の前立腺がんに対する心臓オンコロジー相談(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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前:Clinical Trial Recruitment Navigator
- 電話番号:310-423-5842
- メール:GroupCancerTrialInformation@cshs.org
研究連絡先のバックアップ
- 名前:Katelyn Atkins, MD, PhD
- メール:katelyn.atkins@csmc.edu
研究場所
-
-
California
-
Los Angeles、California、アメリカ、90048
- 募集
- Cedars Sinai Medical Center
-
主任研究者:
- Leslie Ballas, MD
-
主任研究者:
- Katelyn Atkins, MD, PhD
-
コンタクト:
- Clinical Trial Recruitment Navigator
- 電話番号:13104232133
- メール:GroupCancerTrialInformation@cshs.org
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
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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).
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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 |
|
アクティブコンパレータ: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 |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of any CV medication Initiation and/or Change
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Rate of Compliance with CV Therapeutic Medication Intervention
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:12 Months Post-Intervention
|
To determine the one-year MACE rate |
12 Months Post-Intervention
|
|
Rate of Grade ≥ 2 Cardiac CTCAE
時間枠:12 Month Post-Intervention
|
To determine one-year rate of grade ≥ 2 cardiac common terminology criteria for adverse events (CTCAE) |
12 Month Post-Intervention
|
協力者と研究者
捜査官
- 主任研究者:Katelyn Atkins, MD, PhD、Cedars-Sinai Medical Center
- 主任研究者:Leslie Ballas, MD、Cedars-Sinai Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IIT2025-09-BALLAS-ATKINS-HEART
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