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Recruiting Phase 2 NCT05054296

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

Trial Parameters

Condition Biochemically Recurrent Prostate Carcinoma
Sponsor M.D. Anderson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 200
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2020-03-23
Completion 2027-02-02
Interventions
Educational InterventionExercise InterventionFitBit

Brief Summary

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.

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 wil

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