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New treatment option for Prostate Cancer (Diagnosis)
Official title High Cardiovascular Risk Intervention With Cardio-Oncology Consultation for Prostate Cancer Following Androgen Receptor Pathway Inhibitor (ARPI) Therapy (Heart-Safe)
ClinicalTrials.gov ID: NCT07223385
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older, men only
You may be able to join if
- 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
You likely can't join if
- Prior ARPI therapy exposure \> 6 months duration.
- Established care with cardio-oncologist (cardiologist with expertise in CV risks of cancer and cardiotoxic cancer therapies).
See the full eligibility 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.
- Prior ARPI therapy exposure \> 6 months duration.
- Established care with cardio-oncologist (cardiologist with expertise in CV risks of cancer and cardiotoxic cancer therapies).
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.