Prostate Cancer Clinical Trial
— PCTOfficial title:
Cardiotoxicity of Prostate Cancer Therapy: Mechanisms, Predictors, and Social Determinants of Health in Prostate Cancer Patients Treated With Androgen Deprivation Therapy
NCT number | NCT05096338 |
Other study ID # | UPCC 12821 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 27, 2021 |
Est. completion date | October 2028 |
This is an observational study for patients with prostate cancer that will be treated with Androgen Deprivation Therapy. The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). Patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. Patients will be followed on this study for up to 5 years.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | October 2028 |
Est. primary completion date | October 2028 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Men older than 18 years of age Prostate cancer diagnosis planned for treatment with =6 months of ADT (with or without RT) for clinically localized, biochemically recurrent, or oligometastatic disease. Planned ADT regimens may include: GnRH agonists (goserelin, histrelin, leuprolide, triptorelin) with or without first-generation anti-androgens and GnRH antagonists (degarelix). Additional systemic agents, including second-generation androgen receptor signaling inhibitors, may be used in combination with GnRH agonist/antagonist therapies per provider clinical discretion. Ability to provide informed consent Exclusion Criteria: Prior ADT injection within 6 months prior to enrollment Inability or unwillingness to provide consent |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center at Penn Medicine | American Heart Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Left Ventricular Ejection Fraction (LVEF) | Absolute change in LVEF by echocardiogram at follow-up | through study completion (expected to be 15 years) | |
Secondary | Cancer therapy-related cardiac dysfunction (CTRCD) | Incidence of CTRCD defined as at least a 10% absolute change in LVEF by echocardiogram at follow-up relative to baseline to a value < 50% | through study completion (expected to be 15 years) | |
Secondary | Symptomatic Heart Failure (HF) | Incidence of symptomatic heart failure (centrally adjudicated) | through study completion (expected to be 15 years) | |
Secondary | Change in Longitudinal Strain | Change in longitudinal strain by echo from baseline | through study completion (expected to be 15 years) | |
Secondary | Change in Circumferential Strain | Change in circumferential strain by echo from baseline | through study completion (expected to be 15 years) | |
Secondary | Change in Diastolic function | Change in diastolic function defined as E/e' by echo from baseline | through study completion (expected to be 15 years) | |
Secondary | Change in Left Ventricular (LV) Mass | Change in LV Mass by echo from baseline | through study completion (expected to be 15 years) | |
Secondary | Change in Relative LV Wall Thickness | Change in relative LV wall thickness from baseline | through study completion (expected to be 15 years) | |
Secondary | Change in Ventricular-Arterial Coupling | Change in Ventricular-Arterial Coupling defined as Ea/Ees by echo from baseline | through study completion (expected to be 15 years) | |
Secondary | Change in LV Twist | Change in LV Twist measured by 3D echo from baseline | through study completion (expected to be 15 years) | |
Secondary | Change in LV Torsion | Change in LV Torsion measured by 3D echo from baseline | through study completion (expected to be 15 years) | |
Secondary | Change in NTproBNP | Change in NTproBNP measured in batches from banked samples from baseline. | through study completion (expected to be 15 years) | |
Secondary | Change in high-sensitivity troponin (hsTnT) | Change in hs-TnT measured in batches from banked samples from baseline. | through study completion (expected to be 15 years) | |
Secondary | Change in patient reported fatigue | Change in Patient Reported Outcomes Information System (PROMIS) Fatigue Score from baseline. A higher score corresponds to higher reported levels of fatigue. | through study completion (expected to be 15 years) | |
Secondary | Change in patient reported quality of life | Change in Patient Reported Outcomes Information System (PROMIS) Global Health score from baseline. Higher scores indicate a healthier patient. | through study completion (expected to be 15 years) | |
Secondary | Change in patient reported activity level | Change in total weekly leisure activity in METS assessed by Godin Leisure Time Exercise Questionnaire from baseline. | through study completion (expected to be 15 years) |
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