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Exercise and Fitbit Monitoring for Prostate Cancer Patients on ADT

This study is for men with prostate cancer that has spread (metastatic) or come back after treatment (recurrent), and who are receiving androgen deprivation therapy (ADT). ADT can cause side effects like metabolic syndrome and heart problems. This trial is testing if a 16-week exercise program, combined with continuous Fitbit monitoring, can help improve your heart health and manage metabolic syndrome. The main goal is to see how this program affects your 10-year risk of heart disease. You may be able to join if you have prostate adenocarcinoma, have metastatic disease or biochemical recurrence, and are willing to provide consent. The study aims to enroll 200 participants.

Study design
This is an interventional study, but the phase is not specified. It plans to enroll 200 male participants.
What's involved
You would participate in supervised and self-directed exercise sessions, wear a Fitbit for activity tracking, and complete quality-of-life assessments and questionnaires. The exercise program lasts 16 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your heart disease risk will be measured through the study completion, which is an average of one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05054296

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

Recruiting
PHASE2Ages 18+InterventionalSupportive care
M.D. Anderson Cancer Center
~200 participants
Updated 2023-03-29 on ClinicalTrials.gov
What's tested:Educational InterventionExercise InterventionFitBitQuality-of-Life AssessmentQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Atherosclerotic cardiovascular disease (ASCVD) 10-year risk score
Measured over Through the study completion, an average of a year.

Conditions

Biochemically Recurrent Prostate Carcinoma
Metastatic Prostate Adenocarcinoma
Stage IV Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Christopher J Logothetis · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Christopher J Logothetis
[email protected]
7135637210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Atherosclerotic cardiovascular disease (ASCVD) 10-year risk scoreThrough the study completion, an average of a year.

    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