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New treatment option for Biochemically Recurrent Prostate Carcinoma
Official title Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring
ClinicalTrials.gov ID: NCT05054296
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 16 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- 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
You likely can't join if
- Current use of any other systemic therapy for prostate cancer with the exception of gonadotrophin releasing hormone (GnRH) agonists/antagonists...
- Any underlying comorbid medical or psychiatric condition, which in the opinion of the Investigator, will make participation in our exercise...
- 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
See the full eligibility 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...
- 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...
- 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...
- Untreated symptomatic spinal cord compressions
- Prisoners or people who are involuntarily incarcerated
- people who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.