RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 16 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Measure the relationship between the exercise intervention and physical activity (as measured by the Godin Leisure Time Physical Activity Questionnaire) compared to Fitbit monitoring alone."
  • "Patients also wear a FitBit daily over 16 weeks."
  • "GROUP II: Patients participate in supervised and self-directed exercise sessions over 60 minutes twice a week (BIW) for up to 16 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This phase II trial studies how well an exercise program and continuous Fitbit monitoring work for managing metabolic syndrome and cardiovascular disease risk in patients with prostate cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and does not response to treatment (refractory) and are receiving androgen deprivation therapy. Balancing treatment efficacy, drug side effects, and competing comorbidities with prostate cancer is essential. This trial is being done to learn if an exercise program can help to improve metabolic syndrome and cardiovascular (heart) fitness in prostate cancer patients who are receiving androgen deprivation therapy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (1)

TX

  • M D Anderson Cancer Center · Houston, TX 77030Christopher J. Logothetis · Study contact · 713-792-2830Christopher J. Logothetis · Principal investigatorMore trials in Houston