CCTA for Heart Health in Prostate Cancer Patients

Overseen By Ashley Hutchison

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

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. ^{1 2 3 4 5}

Is 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. ^{2 6 7 8 9}

How 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. ^{2 4 10 11 12}

Research Team

Suparna C. Clasen, MD, MSCE

Principal Investigator

Indiana University

Eligibility 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).

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.

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical Utility and Prognostic Value of Coronary Computed Tomography Angiography in Patients With Cancer. [2023]

2. England 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. [2023]

3. Croatia pubmed.ncbi.nlm.nih.gov

Influence of coronary computed tomography-angiography on patient management. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of cardiac computed tomographic angiography findings on planning of cancer therapy in patients with concomitant structural heart disease. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Coronary Computed Tomography Angiography Improving Outcomes in Patients with Chest Pain. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of combining multiple dose reduction techniques on coronary computed tomography angiography. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of renal function tests by age and sex to determine emergency department patients' eligibility for cardiac computed tomography. [2019]

8. Saudi Arabia 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. [2022]

9. Germany 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. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Coronary CT angiography can be used as a substitute for coronary angiography in patients with significant LV dysfunction. [2016]

11. Germany pubmed.ncbi.nlm.nih.gov

Predictive and prognostic value of 256-slice computed tomography angiography in patients with suspected coronary artery diseases. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Coronary Computed Tomography Angiography as a Gatekeeper to Coronary Revascularization: Emphasizing Atherosclerosis Findings Beyond Stenosis. [2022]