OncoMatch/Clinical Trials/NCT05054296
Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring
Is NCT05054296 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies FitBit for biochemically recurrent prostate carcinoma.
Treatment: FitBit — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage IV, IVA, IVB
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: gonadotropin-releasing hormone agonist or antagonist, or surgical castration
On gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or status post-surgical castration for at least 3 months
Cannot have received: chemotherapy
Chemotherapy treatment within 28 days of study enrollment
Cannot have received: investigational pharmaceutical products
Any investigational pharmaceutical products
Cannot have received: radiation therapy or surgical intervention for prior bone metastasis
Radiation therapy or surgical intervention for prior bone metastasis
Cannot have received: systemic therapy for prostate cancer
Exception: GnRH agonists/antagonists, abiraterone, enzalutamide, bisphosphonates or RANK-ligand inhibitors (for bone metastases) which are allowed
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
Lab requirements
Blood counts
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
Cardiac function
Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (>= 450 m/sec) [excluded]; 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 [excluded]
Hemoglobin >= 9.0 g/dL...; Platelet count >=75,000/uL...; Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (>= 450 m/sec) [excluded]; 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 [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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