Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring
Recruiting
Phase 2
Interventional Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 200 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Other
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About This Trial
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 effica…
Trial Locations
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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 b…
Contacts