CCTA for Heart Health in Prostate Cancer Patients

Recruiting at 2 trial locations

Overseen By Abhishek Khemka, MD

Age: 18+

Sex: Male

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how Coronary CT Angiography (CCTA), a heart imaging test, can aid in managing heart health in prostate cancer patients. It specifically targets those starting or already undergoing androgen deprivation therapy (ADT), a common treatment for prostate cancer. Participants will be divided into two groups: one receiving CCTA and the other receiving usual care. Ideal candidates have prostate cancer and have been on ADT for over a year, with risk factors for heart disease such as high blood pressure or diabetes, but without current heart symptoms. As an unphased trial, this study offers a unique opportunity to enhance understanding of heart health management in prostate cancer patients.

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 prior data suggests that Coronary CT Angiography is safe for prostate cancer patients on androgen deprivation therapy?

Research shows that Coronary CT Angiography (CCTA) safely and effectively examines the heart's blood vessels. As a non-invasive test, it does not involve surgery or entering the body and is used to detect coronary artery disease. One study found that CCTA accurately identifies people with the disease, achieving a high accuracy rate of 94.6%. It also correctly identifies those without the disease most of the time, with an accuracy rate of 76%.

While patients generally tolerate CCTA well, some risks exist, as with any medical test. These include radiation exposure and the possible use of contrast dye, which enhances the visibility of blood vessels. Some individuals may react to this dye, but these risks are usually considered low.

Overall, CCTA is widely used because it provides important information about heart health with minimal discomfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Coronary CT Angiography (CCTA) for heart health in prostate cancer patients because it offers a non-invasive way to get detailed images of the heart's blood vessels. Unlike traditional stress tests or invasive angiographies, CCTA provides precise and rapid visualization, helping to detect coronary artery issues early. This is particularly beneficial for prostate cancer patients, who might be at higher risk of heart problems due to their treatment regimens. By using CCTA, doctors hope to better tailor heart care for these patients, potentially improving outcomes and personalizing their treatment plans.

What evidence suggests that Coronary CT Angiography is effective for heart health in prostate cancer patients?

Research has shown that Coronary CT Angiography (CCTA), which participants in this trial may receive, effectively rules out coronary artery disease (CAD), with one study finding this in 98.6% of cases. This indicates that CCTA excels at confirming the absence of blocked heart arteries. Other studies have identified CCTA as the best noninvasive method for diagnosing heart artery problems compared to tests like exercise stress tests or echo tests. It also helps detect early signs of artery disease in cancer patients. Overall, CCTA serves as a powerful tool for assessing heart health, especially when other tests might miss problems. ^{6 7 8 9 10}

Who Is on the Research Team?

Abhishek Khemka, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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).

Exclusion Criteria

Allergy to iodinated contrast

My kidneys are not working well, with a creatinine clearance below 35ml/min.

Patient has implantable cardioverter-defibrillator (ICD), or pacemaker

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Coronary CT Angiography (CCTA)

Trial Overview 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.

How Is the Trial Designed?

Group I: CCTA Group Experimental Treatment 1 Intervention

Group II: Usual Care Group Active Control 1 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

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Myovant Sciences GmbH

Industry Sponsor

Trials

23

Recruited

12,500+

National Comprehensive Cancer Network

Collaborator

Trials

121

Recruited

7,400+

Sumitomo Pharmaceuticals America

Industry Sponsor

Trials

5

Recruited

300+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Using multiple dose reduction techniques in coronary computed tomography angiography (CCTA) significantly lowered the average effective radiation dose from 3.36 mSv to 1.13 mSv, which is a substantial reduction and addresses concerns about radiation exposure.

Despite the lower radiation dose in the dose reduction group, the image quality remained excellent, with no significant difference in subjective image quality scores between the groups, indicating that safety can be improved without compromising diagnostic effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of combining multiple dose reduction techniques on coronary computed tomography angiography. Hu, XL., Huang, PK., Zhang, M., et al.[2023]

In a study of 2398 patients with chest pain, 16% were excluded from coronary computed tomography angiography (CCTA) due to high-risk features or technical limitations, highlighting the importance of careful patient selection.

The analysis revealed that using serum creatinine (SCr) cutoffs tends to exclude more males, while glomerular filtration rate (GFR) cutoffs tend to exclude more females, indicating that the choice of renal function test can impact eligibility for CCTA differently based on sex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of renal function tests by age and sex to determine emergency department patients' eligibility for cardiac computed tomography. Rogg, J., Hoffmann, U., Truong, Q., et al.[2019]

In a study of 779 patients with thoracic tumors scheduled for non-cardiac surgery, CCTA revealed that 18.6% had significant coronary artery disease (CAD), which influenced surgical decision-making.

The severity and number of coronary artery stenoses were found to be independent predictors of surgery cancellations, highlighting the importance of CCTA in assessing perioperative cardiac risk and potentially reducing cardiovascular events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary CT angiography for preoperative evaluation of non-cardiac surgery in patients with thoracic tumors: preliminary exploratory analysis in a retrospective cohort. Liao, M., Tang, M., Cao, X., et al.[2023]

In a study of 425 patients with suspected coronary artery disease (CAD), CCTA revealed that 65.5% had normal coronary arteries, which were associated with no major cardiac events during an average follow-up of about 20 months.

Patients with obstructive CAD (≥50% stenosis) had a significantly higher rate of major cardiac events (17.7%) compared to those with nonobstructive (8.2%) and normal coronary arteries (1%), highlighting the efficacy of CCTA in predicting patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive and prognostic value of 256-slice computed tomography angiography in patients with suspected coronary artery diseases. Abazid, RM., Almeman, A., Eldesoky, AF., et al.[2022]

In a study of 9338 patients with stable coronary artery disease (CAD) followed for nearly 10 years, those with obstructive CAD had the highest rates of major adverse cardiovascular events (MACEs) at 19.8%, compared to 10.3% for non-obstructive CAD and 5.5% for no CAD.

Patients treated with statins alone had the lowest risk of MACEs across all CAD categories, with significant reductions in risk, while those with obstructive CAD benefited even more from combination treatments like statins with aspirin or early revascularization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of coronary CT angiography in selection of treatment modalities and subsequent cardiovascular events in Thai patients with stable CAD. Limpijankit, T., Jongjirasiri, S., Meemook, K., et al.[2023]

In a study of 113 cancer patients, coronary computed tomography angiography (CTA) effectively identified coronary artery disease (CAD), leading to the initiation of statin therapy in 88% of patients with potentially obstructive CAD.

The study found no major adverse cardiovascular events (MACEs) during a median follow-up of 9 months, indicating that coronary CTA can safely guide treatment decisions without increasing cardiovascular risks in patients undergoing cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utility and Prognostic Value of Coronary Computed Tomography Angiography in Patients With Cancer. Nazir, MS., Murphy, T., Poku, N., et al.[2023]

In a study of 80 cancer patients, cardiac computed tomographic angiography (CCTA) was effective in diagnosing chemotherapy-induced cardiomyopathy in 22.5% of cases and detecting severe coronary artery disease (CAD) in 27.5% of patients.

CCTA significantly influenced cancer management decisions for over half (51.3%) of the patients, highlighting its importance in evaluating heart health alongside cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of cardiac computed tomographic angiography findings on planning of cancer therapy in patients with concomitant structural heart disease. Daher, IN., Banchs, J., Yusuf, SW., et al.[2021]

Heart failure, often caused by ischemic heart disease, leads to high rates of illness and death, making early evaluation for coronary artery disease crucial for affected patients.

Coronary computed tomography angiography (CCTA) is highlighted as a promising non-invasive alternative to traditional invasive coronary angiography for assessing coronary arteries in patients with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary CT angiography can be used as a substitute for coronary angiography in patients with significant LV dysfunction. Nakanishi, R., Park, HB., Arsanjani, R., et al.[2016]

In a study of 162 patients, the FLASH protocol for coronary computed tomography angiography (CCTA) provided superior image quality compared to the SAS protocol, with higher signal and signal-to-noise ratio.

The FLASH protocol also significantly reduced radiation exposure by 62%, making it a safer option for patients undergoing CCTA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-fast, low dose high-pitch (FLASH) versus prospectively-gated coronary computed tomography angiography: Comparison of image quality and patient radiation exposure. Smettei, OA., Sayed, S., M Al Habib, A., et al.[2022]

Coronary computed tomography-angiography (CCTA) effectively excluded obstructive coronary artery disease (CAD) in 666 out of 792 patients, leading to a 98.6% rate of being free from major adverse cardiac events during a 12-month follow-up.

CCTA significantly reduced the need for cardiac catheterization in 77.2% of patients, regardless of their risk level, and allowed for changes in medical therapy for over half of the patients with confirmed CAD, demonstrating its potential to optimize patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of coronary computed tomography-angiography on patient management. Jukić, M., Pavić, L., Cerkez Habek, J., et al.[2021]

Coronary computed tomography angiography (CCTA) is highly effective in ruling out coronary artery disease (CAD) and provides better diagnostic accuracy for assessing myocardial ischemia compared to traditional stress tests.

Recent trials indicate that using CCTA to guide decisions for invasive coronary angiography (ICA) and revascularization leads to improved patient care and reduced healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary Computed Tomography Angiography as a Gatekeeper to Coronary Revascularization: Emphasizing Atherosclerosis Findings Beyond Stenosis. van den Hoogen, IJ., van Rosendael, AR., Lin, FY., et al.[2022]

Recent randomized controlled trials show that coronary computed tomography angiography (CCTA) significantly improves diagnosis and management for patients with chest pain, leading to better clinical outcomes.

CCTA helps avoid unnecessary invasive procedures and is associated with lower long-term rates of heart attacks, suggesting it should be the preferred initial test for investigating coronary heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary Computed Tomography Angiography Improving Outcomes in Patients with Chest Pain. Tzolos, E., Newby, DE.[2022]

Citations

1. withpower.com withpower.com/trial/phase-prostatic-neoplasms-5-2023-c797c

CCTA for Heart Health in Prostate Cancer Patients Coronary computed tomography-angiography (CCTA) effectively excluded obstructive coronary artery disease (CAD) in 666 out of 792 patients, leading to a 98.6% ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002914923008822

Clinical Utility and Prognostic Value of Coronary Computed ... Coronary CT angiography (CTA) has been shown to have an excellent negative predictive value in the primary diagnosis of coronary artery disease ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8702811/

Cardiac Computed Tomography in Cardio-Oncology: JACC Cardiac computed tomography (CT) can be helpful in identifying both clinical and subclinical ASCVD in cancer patients and survivors.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39143443/

The effectiveness of coronary computed tomography ... Coronary computed tomography angiography showed significantly better diagnostic performance (p < 0.0001) for diagnosis of coronary artery disease compared ...

5. journals.lww.com journals.lww.com/jrs/fulltext/2024/07000/current_status_of_coronary_computed_tomography.1.aspx

Current Status of Coronary Computed Tomography ... CCTA is currently the best noninvasive test for the diagnosis of coronary obstruction compared to other tests such as exercise treadmill, stress echo, and SPECT ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6109833/

Accuracy and clinical outcomes of coronary CT ... In the per-patient accuracy analysis group comprising 101 patients, there were six true negatives, one false negative, 81 true positives and 13 false positives, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1934592525000887

Coronary computed tomography angiography to guide ... Coronary computed tomography angiography (CCTA) is the gold-standard, non-invasive method for detecting coronary artery disease (CAD).4 Clinical practice ...

8. diagnosticimaging.com diagnosticimaging.com/view/meta-analysis-ct-angiography-spect-functional-testing-obstructive-cad

Meta-Analysis Shows Superiority of CT Angiography Over ... Coronary CTA demonstrates significantly higher sensitivity (94.6 percent) and specificity (76 percent) compared to SPECT and exercise-ECG for ...

9. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.107.670042

Screening High-Risk Patients With Computed Tomography ... This article briefly discusses previous efforts utilizing CT-defined coronary calcification as a CAD screening tool in asymptomatic individuals ...

10. cms.gov cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=206&ver=17&NcaName=Computed+Tomographic+Angiography&DocID=CAG-00385N

NCA - Computed Tomographic Angiography (CAG-00385N) Contrast-enhanced 16-slice CT seems to be reasonably sensitive and specific for the detection of significant coronary artery disease but has shortcomings.