Cardiovascular Risk and Health Literacy Among Men with Prostate Cancer
S
Suparna C. Clasen, MD, MSCE
Primary Investigator
J
Jordan Holmes
Primary Investigator
Enrolling By Invitation
18 years - 100 years
Male
Phase
N/A
4 Locations
Brief description of study
What is the purpose of this study?
To compare cardiovascular health literacy, cardiovascular risk, and cardiovascular disease between African American and White men who are receiving or completed androgen deprivation for treatment of prostate cancer. To explore clinical, socioeconomic, and demographic predictors of CVD health literacy.
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
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- This is a prospective cohort study designed to evaluate the cardiovascular health literacy, cardiovascular risk, and cardiovascular preventive care of men receiving hormonal therapy as part of definitive treatment for prostate cancer.
- The study is designed to oversample AA men to allow comparisons between White and AA patients from Indiana University Simon Comprehensive Cancer Center, Indiana University Health Schwarz Cancer Center, Indiana University West Hospital, and Eskenazi Health.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Non-metastatic prostate cancer
-
Age: 18 years - 100 years
-
Gender: Male
Inclusion Criteria:
• Male
• Age ≥18 years old at time of consent.
• African American or White
• Written informed consent and HIPAA authorization for release of personal health
information
• Histologically-confirmed, non-metastatic prostate cancer
• Patients who received external beam radiation treatment and androgen deprivation
therapy (total ADT duration > 3 months) for curative intent treatment starting ADT at
least 12 months ago
• Patients currently on or planned for treatment with ADT plus androgen pathway inhibitor
(abiraterone, enzalutamide, apalutamide, darolutamide) are allowed
• Ability to read and write in English
• No mental disability which would preclude completion of questionnaires
• Male
• Age ≥18 years old at time of consent.
• African American or White
• Written informed consent and HIPAA authorization for release of personal health
information
• Histologically-confirmed, non-metastatic prostate cancer
• Patients who received external beam radiation treatment and androgen deprivation
therapy (total ADT duration > 3 months) for curative intent treatment starting ADT at
least 12 months ago
• Patients currently on or planned for treatment with ADT plus androgen pathway inhibitor
(abiraterone, enzalutamide, apalutamide, darolutamide) are allowed
• Ability to read and write in English
• No mental disability which would preclude completion of questionnaires
Exclusion Criteria:
• Inability to provide informed consent.
• Serious medical or psychiatric illness likely to interfere with participation in this study.
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for
a minimum of 3 years.
• Previous treatment with ADT outside of the index prostate cancer
• Inability to provide informed consent.
• Serious medical or psychiatric illness likely to interfere with participation in this study.
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for
a minimum of 3 years.
• Previous treatment with ADT outside of the index prostate cancer
Updated on
18 Feb 2025.
Study ID: CTO-IUSCCC-0839, 22993
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
