Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring

Launched by M.D. ANDERSON CANCER CENTER · Sep 13, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how a special exercise program and using a Fitbit to track activity can help prostate cancer patients manage their heart health and a condition called metabolic syndrome while they are receiving treatment. Metabolic syndrome can increase the risk of heart disease, which is important for patients with prostate cancer who may already have other health concerns. The study is for men aged 65 to 74 who have prostate cancer that has either come back or spread to other parts of the body and are undergoing a specific type of hormone therapy.

To participate, patients need to be able to walk and complete a stress test, have stable disease activity, and be on certain types of hormone treatments for at least three months. They will be monitored closely during the exercise program, which will be tailored to their abilities. The goal is to see if improving physical fitness can help these patients feel better and reduce their risk of heart problems. It’s important to note that patients with certain health conditions or those currently undergoing chemotherapy may not be eligible for this trial.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Willing and able to provide written informed consent
• • Histologically or cytologically confirmed adenocarcinoma of the prostate
• • Presence of metastatic disease documented on imaging studies (bone scan, computed tomography \[CT\] and/or magnetic resonance imaging \[MRI\]) or biochemical recurrence/refractoriness following local therapy (prostatectomy or radiation)
• • Stable or improving disease activity as demonstrated by stable or improving PSA over at least 2 months
• • On gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or status post-surgical castration for at least 3 months
• • Combination ADT with abiraterone or enzalutamide is permitted
• • Anticipation to remain hypogonadal for at least 6 months subsequently
• • Asymptomatic bone metastasis is permissible (exercise will be modified and patients monitored)
• • Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
• • Patients must be able to finish a maximal exercise stress test which will be assessed by cardiopulmonary exercise testing using a standardized protocol \^70 supervised by a cardiologist
• • Hemoglobin \>= 9.0 g/dL independent of transfusion and/or growth factors within 3 months prior to enrollment
• • Platelet count \>=75,000/uL independent of transfusion and/or growth factors within 3 months prior to enrollment
• • Access to a smart phone with android or iPhone OS (iOS) operating systems
• • Able to speak and comprehend English
• Exclusion Criteria:
• • Current use of any other systemic therapy for prostate cancer with the exception of gonadotrophin releasing hormone (GnRH) agonists/antagonists, abiraterone, enzalutamide, bisphosphonates or RANK-ligand inhibitors (for bone metastases) which are allowed
• • Any underlying comorbid medical or psychiatric condition, which in the opinion of the Investigator, will make participation in our exercise intervention hazardous or obscure the interpretation of adverse events
• • Inability to walk 400 meters or undertake upper and lower limb exercise, and resistance training in the previous 3 months
• • Chemotherapy treatment within 28 days of study enrollment
• • Symptomatic bone metastasis
• • Any investigational pharmaceutical products
• • Radiation therapy or surgical intervention for prior bone metastasis
• • Clinically significant active malignancy other than prostate cancer
• • Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\>= 450 m/sec)
• • Clinically significant heart disease that may impact safety of independent or supervised exercise including preexisting coronary artery disease, myocardial infarction or arterial thrombotic events in the past 6 months, severe or unstable angina, history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de pointes), New York Heart Association Class III-IV heart disease or cardiac ejection fraction measurement of \< 40% at baseline
• • Untreated symptomatic spinal cord compressions
• • Prisoners or subjects who are involuntarily incarcerated
• • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness