RECRUITING

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

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-03-23

Study Completion:2027-02-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05054296

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Christopher J Logothetis

CONTACT

7135637210

clogothe@mdanderson.org

Principal Investigator

Christopher J Logothetis

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Christopher J Logothetis, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-23

Study Completion Date2027-02-02

Study Record Updates

Study Start Date2020-03-23

Study Completion Date2027-02-02

Terms related to this study

Additional Relevant MeSH Terms

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