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

Korábbi kezelés

• 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
• Radiation therapy or surgical intervention for prior bone metastasis

Más betegség

• 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
• Clinically significant active malignancy other than prostate cancer
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness

Laborértékek

• 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

Egyéb

• Symptomatic bone metastasis
• Any investigational pharmaceutical products
• Untreated symptomatic spinal cord compressions
• Prisoners or subjects who are involuntarily incarcerated

• 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