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NCT07223385 · ClinicalTrials.gov registry record · Phase 2
High Cardiovascular Risk Intervention With Cardio-Oncology Consultation for Prostate Cancer Following Androgen Receptor Pathway Inhibitor (ARPI) Therapy (Heart-Safe)
A Phase 2 study, sponsored by Cedars-Sinai Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT07223385 is a Phase 2 study that is actively recruiting participants, run by Cedars-Sinai Medical Center. The registered enrollment target is 80 participants.
The verdict
NCT07223385, a Phase 2 study, is actively recruiting participants, sponsored by Cedars-Sinai Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
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 metabol
Interventions
- OTHER Cardio-Oncology Referral
- OTHER Notification to PCP/General Cardiologist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-08-01 |
| Est. Completion | 2030-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07223385
The ClinicalTrials.gov registry entry for NCT07223385 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cardio-Oncology Referral is the first listed.
NCT07223385 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07223385 about?
NCT07223385 is a clinical study titled "High Cardiovascular Risk Intervention With Cardio-Oncology Consultation for Prostate Cancer Following Androgen Receptor Pathway Inhibitor (ARPI) Therapy (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 contribu...
What is the current status of trial NCT07223385?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2026-08-01. Estimated completion is 2030-08.
What interventions are being tested in trial NCT07223385?
The interventions under investigation include: Cardio-Oncology Referral (OTHER), Notification to PCP/General Cardiologist (OTHER).
Who is sponsoring clinical trial NCT07223385?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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