CCTA for Heart Health in Prostate Cancer Patients
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
Must be taking: Androgen deprivation therapy
Must not be taking: Chemotherapy, Sildenafil, Tadalafil
Disqualifiers: ICD, Pacemaker, Coronary stents, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a randomized pilot study of Coronary CT Angiography (CCTA) for coronary atherosclerosis vs. Usual Care in patients with prostate cancer who are either planning to begin, or are currently taking androgen deprivation therapy (ADT) .
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those taking certain medications like sildenafil or tadalafil for specific conditions. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the treatment Coronary CT Angiography (CCTA) for heart health in prostate cancer patients?
Research shows that Coronary CT Angiography (CCTA) is useful in detecting coronary artery disease (CAD) in cancer patients, which helps in making important treatment decisions. In one study, CCTA-guided approaches led to preventative therapies and allowed most patients to continue their cancer treatments without major heart issues.
12345Is Coronary CT Angiography (CCTA) safe for humans?
CCTA is generally safe, but it involves exposure to radiation, which is a concern for some people. Additionally, there is a risk of kidney problems from the contrast dye used during the procedure.
26789How is the treatment Coronary CT Angiography (CCTA) unique for heart health in prostate cancer patients?
Coronary CT Angiography (CCTA) is unique because it is a non-invasive imaging test that helps evaluate coronary artery disease (CAD) without the need for traditional invasive procedures. It can influence treatment decisions by providing detailed images of the heart's blood vessels, which is particularly useful for cancer patients who may have additional heart health concerns.
24101112Eligibility Criteria
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.Inclusion Criteria
I am 40 years old or older.
I am currently on or will start hormone therapy with specific medications for my cancer.
I have at least one risk factor for heart disease (high blood pressure, high cholesterol, diabetes, or I use tobacco).
+3 more
Exclusion Criteria
Allergy to iodinated contrast
My kidneys are not working well, with a creatinine clearance below 35ml/min.
I am taking medication for blood flow, lung pressure, or prostate enlargement.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to either the CCTA group or usual care group, with treatment tailored based on plaque assessment
12 months
Regular visits as per study protocol
Follow-up
Participants are monitored for changes in ASCVD risk score and other cardiovascular risk factors
6 months
Follow-up assessments at 6 and 12 months
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: CCTA GroupExperimental Treatment1 Intervention
Group II: Usual Care GroupActive Control1 Intervention
Coronary CT Angiography (CCTA) is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Coronary CT Angiography for:
- Diagnosis of coronary artery disease
- Evaluation of coronary artery stenosis
- Assessment of coronary bypass grafts
🇺🇸 Approved in United States as Coronary CT Angiography for:
- Diagnosis of coronary artery disease
- Evaluation of coronary artery stenosis
- Assessment of coronary bypass grafts
- Preoperative assessment for non-coronary cardiac surgery
🇨🇦 Approved in Canada as Coronary CT Angiography for:
- Diagnosis of coronary artery disease
- Evaluation of coronary artery stenosis
- Assessment of coronary bypass grafts
🇯🇵 Approved in Japan as Coronary CT Angiography for:
- Diagnosis of coronary artery disease
- Evaluation of coronary artery stenosis
- Assessment of coronary bypass grafts
🇨🇳 Approved in China as Coronary CT Angiography for:
- Diagnosis of coronary artery disease
- Evaluation of coronary artery stenosis
- Assessment of coronary bypass grafts
🇨🇭 Approved in Switzerland as Coronary CT Angiography for:
- Diagnosis of coronary artery disease
- Evaluation of coronary artery stenosis
- Assessment of coronary bypass grafts
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, IN
Loading ...
Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
Myovant Sciences GmbHIndustry Sponsor
National Comprehensive Cancer NetworkCollaborator
Sumitomo Pharmaceuticals AmericaIndustry Sponsor
PfizerIndustry Sponsor
References
Clinical Utility and Prognostic Value of Coronary Computed Tomography Angiography in Patients With Cancer. [2023]There is growing interest in the role of coronary computed tomography angiography (CTA) in cardio-oncology. However, there is a paucity of real-world experience and outcome data for patients with cancer. This study sought to determine the clinical utility and prognostic value of coronary CTA in patients with cancer. In this prospective, single-center study, we recruited patients with cancer who underwent coronary CTA. Coronary artery disease (CAD) extent was classified as normal, nonobstructive (1% to 49% stenosis), and potentially obstructive (≥50% stenosis). Patients were followed up for a median of 9 months (interquartile range 3 to 30 months) for cancer-related deaths and major adverse cardiovascular events (MACEs) defined as nonfatal myocardial infarction, urgent unplanned revascularization, or cardiovascular death. The mean age of patients (n = 113) was 61 ± 12 years, and 68 were female (60%). The most common underlying cancers were breast (29%) and lymphoma (13%). A total of 25 patients had potentially obstructive CAD, most commonly of the left anterior descending artery. After coronary CTA, 88% statin-naive patients with potentially obstructive CAD were initiated on statin therapy. A total of 28/32 patients who were taking fluoropyrimidine chemotherapy (5-fluorouracil or capecitabine) continued therapy, of whom none had MACEs. Overall, there were no episodes of MACEs in this cohort and 11% had cancer-related deaths. Coronary CTA has an important role in the clinical decision-making in patients with cancer to detect CAD, initiate primary preventative therapy, and guide coronary revascularization. No MACEs occurred. Using this coronary CTA-guided approach, preventative therapy was initiated, and most patients continued prognostically important cancer therapy.
Coronary CT angiography for preoperative evaluation of non-cardiac surgery in patients with thoracic tumors: preliminary exploratory analysis in a retrospective cohort. [2023]Noninvasive coronary CT angiography (CCTA) was used to retrospectively analyze the characteristics of coronary artery disease (CAD) in patients with thoracic tumors and the impact of the results on clinical surgery decision-making, thus increasing the understanding of perioperative cardiac risk evaluation.
Influence of coronary computed tomography-angiography on patient management. [2021]To evaluate how coronary computed tomography-angiography (CCTA) altered the management and treatment of patients with suspected coronary artery disease (CAD).
Impact of cardiac computed tomographic angiography findings on planning of cancer therapy in patients with concomitant structural heart disease. [2021]Background. Exclusion of underlying coronary artery disease (CAD) is essential in the diagnosis of chemotherapy-induced cardiomyopathy. Presence and severity of CAD can also impact the choice of therapy in cancer patients. The value of cardiac computed tomographic angiography (CCTA) in this setting has not been reported. Methods. We collected data on the clinical presentation and indications for CCTA performed from January to December 2008 at the University of Texas MD Anderson Cancer Center (MDACC). All examinations were performed using a 64-detector scanner. CCTA results and subsequent treatment decisions were examined. Results. A total of 80 patients underwent CCTA during the study period for the following indications (not mutually exclusive): cardiomyopathy of unknown etiology in 33 pts (41.3%), chest pain in 32 (40.0%), abnormal stress test in 16 (20.0%), abnormal cardiac markers in 8 (10.0%), suspected cardiac mass or thrombus in 7 (8.8%). Chemotherapy-induced cardiomyopathy was diagnosed in 18 pts (22.5%). Severe CAD was detected in 22 pts (27.5%); due to concomitant advanced cancer or patient refusal, only 12 underwent coronary angiogram. Of these, 4 pts (5% of total) underwent coronary artery bypass grafting. A total of 41 pts (51.3%) had their cancer management altered based on CCTA findings. Conclusion. CCTA is useful in evaluating cancer pts with structural heart disease and can have an impact on the management of cancer and cardiac disease.
Coronary Computed Tomography Angiography Improving Outcomes in Patients with Chest Pain. [2022]To provide an overview of recent studies of coronary computed tomography angiography (CCTA) and how it has helped to improve clinical outcomes for patients presenting with chest pain.
Effects of combining multiple dose reduction techniques on coronary computed tomography angiography. [2023]Coronary computed tomography angiography (CCTA) is the preferred non-invasive examination method for coronary heart disease. However, the radiation from computed tomography has become a concern since public awareness of radiation hazards continue to increase.
Evaluation of renal function tests by age and sex to determine emergency department patients' eligibility for cardiac computed tomography. [2019]Coronary computed tomography angiography (CCTA) can be used for low-risk chest pain patients, but presents a risk of contrast-induced nephropathy.
Ultra-fast, low dose high-pitch (FLASH) versus prospectively-gated coronary computed tomography angiography: Comparison of image quality and patient radiation exposure. [2022]Coronary computed tomography angiography (CCTA) is increasingly being used for the evaluation of coronary artery disease; however, radiation exposure remains a major limitation of its use.
Impact of coronary CT angiography in selection of treatment modalities and subsequent cardiovascular events in Thai patients with stable CAD. [2023]Coronary computed tomography angiography (CCTA) enables improved diagnosis of subclinical, coronary artery disease (CAD). This retrospective cohort study investigated the association between different treatment modalities guided by CCTA and the prevention of major adverse cardiovascular events (MACEs) in patients with stable CAD.
Coronary CT angiography can be used as a substitute for coronary angiography in patients with significant LV dysfunction. [2016]Heart failure is a complex and progressive disease that leads to significant morbidity and mortality. The clinical manifestations of heart failure may result from a variety of disorders, although ischemic heart disease is the leading cause in Western society. Due to the fact that patients with ischemic heart disease benefit from revascularization, evaluation for obstructive coronary artery disease is recommended in this select population. Traditionally, invasive coronary angiography has been used for evaluation of obstructive coronary disease, however recently coronary computed tomography angiography (CCTA) has emerged as an attractive non-invasive method for the evaluation of coronary arteries. The benefits of CCTA in evaluation of select individuals with heart failure will be summarized in this article.
Predictive and prognostic value of 256-slice computed tomography angiography in patients with suspected coronary artery diseases. [2022]Coronary computed tomography angiography (CCTA) is commonly used to diagnose coronary artery diseases (CADs). We aimed to determine the utility of CCTA among patients suspected with CAD at the Prince Sultan Cardiac Center Qassim.
Coronary Computed Tomography Angiography as a Gatekeeper to Coronary Revascularization: Emphasizing Atherosclerosis Findings Beyond Stenosis. [2022]Coronary computed tomography angiography (CCTA) is the optimal non-invasive test to rule out coronary artery disease (CAD). Decisions to perform coronary revascularization have traditionally been based upon ischemia testing. This review summarizes the latest observations and trials evaluating the suitability of CCTA to select patients for invasive coronary angiography (ICA) and subsequent revascularization.