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Imaging
CCTA for Heart Health in Prostate Cancer Patients
N/A
Recruiting
Led By Suparna C. Clasen, MD, MSCE
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months, and 12 months
Awards & highlights
Study Summary
This trial looks at a heart scan (CCTA) for prostate cancer patients on hormone therapy (ADT) to check for blocked arteries.
Who is the study for?
Men over 40 with prostate cancer who are starting or already on androgen deprivation therapy (ADT) for more than a year can join. They must have at least one risk factor for artery disease like high blood pressure, high cholesterol, diabetes, or tobacco use but no current heart symptoms.Check my eligibility
What is being tested?
The study is testing if using Coronary CT Angiography (CCTA), a special type of imaging scan that looks at the arteries in the heart, is better than usual care in spotting heart vessel problems in men undergoing ADT for prostate cancer.See study design
What are the potential side effects?
CCTA may involve exposure to radiation and contrast dye which can cause allergic reactions or kidney issues. Usual care has no additional side effects beyond standard medical practice.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months, and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Atherosclerosis in CCTA Arm
Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA
Secondary outcome measures
Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CCTA GroupExperimental Treatment1 Intervention
Group II: Usual Care GroupActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Myovant Sciences GmbHIndustry Sponsor
22 Previous Clinical Trials
12,390 Total Patients Enrolled
5 Trials studying Prostate Cancer
4,544 Patients Enrolled for Prostate Cancer
National Comprehensive Cancer NetworkNETWORK
115 Previous Clinical Trials
7,535 Total Patients Enrolled
5 Trials studying Prostate Cancer
301 Patients Enrolled for Prostate Cancer
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
981,662 Total Patients Enrolled
7 Trials studying Prostate Cancer
585 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 40 years old or older.I am currently on or will start hormone therapy with specific medications for my cancer.My kidneys are not working well, with a creatinine clearance below 35ml/min.I have at least one risk factor for heart disease (high blood pressure, high cholesterol, diabetes, or I use tobacco).I do not have any heart-related symptoms.I am taking medication for blood flow, lung pressure, or prostate enlargement.I have a history of heart issues, including stents, blocked arteries, heart attack, bypass surgery, or atrial fibrillation.I cannot take certain medications for a heart scan.I have prostate cancer and am on or will start hormone therapy for over a year.I am currently receiving chemotherapy with docetaxel, cabazitaxel, or mitoxantrone.
Research Study Groups:
This trial has the following groups:- Group 1: CCTA Group
- Group 2: Usual Care Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings to participate in this scientific inquiry?
"According to the data available on clinicaltrials.gov, this particular medical trial has already completed patient recruitment. The original posting was dated June 1st 2023 and no changes have been made since May 19th of the same year. However, there are more than 1315 other trials still actively seeking participants at this point in time."
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