ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

S
Suparna C. Clasen, MD, MSCE

Primary Investigator

Enrolling By Invitation
40 years and older
Male
Phase N/A
100 participants needed
2 Locations

Brief description of study

What is the purpose of this study?
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) .

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What will happen during the study?
  • This is a randomized pilot study where subjects are randomized 1:1 to either the CCTA group or non-CCTA (usual care) group. 
  • The target enrollment will be 100 subjects with accounting for a potential 10% dropout rate resulting in an sample size between 90-100 participants or 45-50per group arm.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Prostate Cancer
  • Age: 40 Years
  • Gender: Male

Inclusion Criteria:
  1. Written informed consent and HIPAA authorization for release of personal health information
  2. Age ≥40 years at time of consent
  3. Previous diagnosis of prostate cancer who are either currently receiving ADT, or who are planning to start ADT for >12 months
  4. Patients currently on or planned for treatment with ADT plus androgen pathway inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide) are allowed
  5. ≥1 risk factor for ASCVD (hypertension, hyperlipidemia, diabetes, tobacco use)
  6. No current cardiac symptoms
Exclusion Criteria:
  1. Concurrent treatment with chemotherapy (docetaxel, cabazitaxel, mitoxantrone) at time of signing consent
  2. Patient has implantable cardioverter-defibrillator (ICD), or pacemaker
  3. History of coronary stents, obstructive coronary artery disease, myocardial infarction, coronary artery bypass grafting. History of atrial fibrillation
  4. Renal dysfunction with creatinine clearance <35ml/min (calculated by Cockcroft-Gault Equation)
  5. Allergy to iodinated contrast
  6. Contraindication to the medications that may be given to regulate heart rate for the CCTA scan (applicable only to those randomized to the CCTA group)
  7. Patients taking sildenafil or tadalafil for vasodilation, pulmonary hypertension, or BPH
    1. Note: Subjects taking sildenafil or tadalafil for erectile disfunction will still be eligible.

Updated on 01 Aug 2024. Study ID: CTO-IUSCCC-0807, 18945
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