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.
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
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
Parallel
Educational Intervention
BehavioralReceive general education exercise packet
Exercise Intervention
BehavioralParticipate in supervised and self-directed exercise sessions
FitBit
DeviceWear FitBit for activity tracking
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Atherosclerotic cardiovascular disease (ASCVD) 10-year risk score
The 16-week exercise program would affect this risk score through reduction of systolic blood pressure (SBP) and cholesterol while increasing high-density lipoprotein (HDL). · A 0 to 4.9 percent risk is considered low. Eating a healthy diet and exercising will help keep your risk low. Medication is not recommended unless your LDL, or "bad" cholesterol, is greater than or equal to 190. * A 5 to 7.4 percent risk is considered borderline. Use of a statin medication may be recommended if you have certain conditions, or "risk enhancers." These conditions may increase your risk of a heart disease or stroke. Talk with your primary care provider to see if you have any of the risk enhancers in the list below. * A 7.5 to 20 percent risk is considered intermediate. It is recommended that you start with moderate-intensity statin therapy. * A greater than 20 percent risk is considered high. It is recommended that you start with high-intensity statin therapy
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
