Actively Recruiting
Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring
Led by M.D. Anderson Cancer Center · Updated on 2023-03-29
200
Participants Needed
1
Research Sites
358 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Metastatic disease documented on imaging or biochemical recurrence/refractoriness after local therapy
- Stable or improving PSA levels for at least 2 months
- On GnRH agonist, antagonist, or surgical castration for at least 3 months
- Combination ADT with abiraterone or enzalutamide allowed
- Expected to remain hypogonadal for at least 6 months
- Asymptomatic bone metastasis allowed with exercise modifications
- ECOG performance status of 0, 1, or 2
- Able to complete a maximal exercise stress test supervised by a cardiologist
- Hemoglobin level of 9.0 g/dL or higher within 3 months prior to enrollment
- Platelet count of 75,000/uL or higher within 3 months prior to enrollment
- Access to a smartphone with Android or iOS
- Able to speak and understand English
You will not qualify if you...
- Current use of systemic therapy for prostate cancer other than GnRH agonists/antagonists, abiraterone, enzalutamide, bisphosphonates, or RANK-ligand inhibitors
- Medical or psychiatric conditions making exercise hazardous or adverse event interpretation difficult
- Inability to walk 400 meters or perform resistance training in past 3 months
- Chemotherapy within 28 days prior to study enrollment
- Symptomatic bone metastasis
- Use of investigational drugs
- Radiation therapy or surgery for prior bone metastasis
- Active significant malignancy other than prostate cancer
- Prolonged QTc interval (≥ 450 msec) on ECG
- Significant heart disease impacting exercise safety, including recent myocardial infarction or unstable angina
- Untreated symptomatic spinal cord compression
- Prisoners or involuntarily incarcerated individuals
- Compulsorily detained for psychiatric or physical illness treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Christopher J Logothetis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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