Exercise and Fitbit monitoring for prostate cancer patients on hormone therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effectiveness of a 16-week exercise program combined with continuous Fitbit monitoring to manage metabolic syndrome and cardiovascular disease risk in prostate cancer patients undergoing androgen deprivation therapy (ADT). The primary objective is to assess changes in cardiovascular fitness, measured by the 10-year atherosclerotic cardiovascular disease risk score, comparing the exercise program to Fitbit monitoring alone. Secondary objectives include evaluating the long-term effects on cardiovascular fitness, metabolic syndrome severity, prostate-specific antigen velocity, and overall physical fitness. The study aims to balance treatment efficacy with the management of comorbidities associated with prostate cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Christopher J Logothetis — M.D. Anderson Cancer Center
• Study coordinator: Christopher J Logothetis
• Email: clogothe@mdanderson.org
• Phone: 7135637210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.