Can Heart-Focused care cut risks for prostate cancer patients?
NCT ID NCT07223385
First seen Jun 24, 2026 · Last updated Aug 07, 2026 · Updated 5 times
Summary
This study tests whether early referral to a cardio-oncology specialist can lower heart risks in prostate cancer patients receiving long-term hormone therapy (ARPI). About 80 men with high-risk or advanced prostate cancer and additional heart risk factors will be assigned to either a cardio-oncology consultation or standard care. The main goal is to see if more heart medications (like statins or blood pressure drugs) are started or adjusted within three months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cardio-oncology consultation (guidelines-based personalized management)
- What this could lead to
- If successful, this could show that early heart-focused care reduces cardiovascular risk in prostate cancer patients on long-term hormone therapy.
- What could go wrong
- This is a small Phase 2 trial (80 people) testing a care process, not a new drug. It may not prove that heart events are actually prevented.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
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Other studies related to the condition(s) this trial covers.
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