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Biochemically Recurrent Prostate CarcinomaPhase 2NCT05054296

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

A Phase 2 study testing Educational Intervention, Exercise Intervention and FitBit in people with Biochemically Recurrent Prostate Carcinoma and Metastatic Prostate Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Educational Intervention, Exercise Intervention and FitBit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
23 Mar 2020to 2 Feb 2027
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christopher J Logothetis contact

7135637210

clogothe@mdanderson.org

United States1 site, 1 recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Christopher J. Logothetis, 713-792-2830

    Christopher J. Logothetis

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Determine the relationship between a 16-week exercise program with continuous Fitbit monitoring and cardiovascular fitness (defined by change in 10-year atherosclerotic cardiovascular disease [ASCVD] risk score), as compared to Fitbit monitoring alone, in prostate cancer patients on androgen deprivation therapy (ADT).

SECONDARY OBJECTIVES:

  1. Determine the length of cardiovascular fitness effect (measured using 10-year ASCVD risk 12 weeks post intervention) for a 16-week exercise program with continuous Fitbit monitoring in prostate cancer patients on ADT.

II. Screen for a relationship between a 16-week exercise program with continuous Fitbit monitoring and metabolic syndrome severity (defined by change in metabolic severity index z-score), as compared to Fitbit monitoring alone, in prostate cancer patients on ADT.

III. Measure the relationship between the exercise intervention and prostate-specific antigen (PSA) velocity, compared to Fitbit monitoring alone.

IV. Measure the relationship between the exercise intervention and physical fitness (using V02 and body composition), compared to Fitbit monitoring alone.

  1. Measure the relationship between the exercise intervention and physical activity (step count)/heart rate, compared to Fitbit monitoring alone.

VI. Measure the relationship between the exercise intervention and physical activity (as measured by the Godin Leisure Time Physical Activity Questionnaire) compared to Fitbit monitoring alone.

VII. Measure the relationship between the exercise intervention and, quality of life/symptom burden, compared to Fitbit monitoring alone (measured by the following patient reported surveys: National Cancer Institute-patient reported outcomes-Common Terminology Criteria for Adverse Events [NCI-PRO-CTCAE], Patient Reported Outcomes Measurement Information System [PROMIS] Fatigue and Physical Function, Self Efficacy, European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Core30 [QLQ-C30] and Prostate Cancer 25 [PR25]).

EXPLORATORY OBJECTIVE:

  1. Explore the relationship between the exercise intervention and markers of insulin resistance, inflammation/immune function and metabolism utilizing pre- and post-intervention peripheral blood analysis.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive general education exercise packet with instruction to exercise regularly for up to 150 minutes weekly. Patients also wear a FitBit daily over 16 weeks.

GROUP II: Patients participate in supervised and self-directed exercise sessions over 60 minutes twice a week (BIW) for up to 16 weeks. Patients also wear a FitBit daily over 16 weeks.

Being tested
Educational Intervention, Exercise Intervention, FitBit, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational InterventionBehavioural

    Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

    Receive general education exercise packet

  • Exercise InterventionBehavioural

    Participate in supervised and self-directed exercise sessions

  • FitBitDevice

    Wear FitBit for activity tracking

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT05054296
Study groupRoleWhat they receive
Group I (education exercise packet, FitBit)Active comparatorPatients receive general education exercise packet with instruction to exercise regularly for up to 150 minutes weekly. Patients also wear a FitBit daily over 16 weeks.
Receives: Behavioral: Educational Intervention; Device: FitBit; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Group II (exercise program FitBit)ExperimentalPatients participate in supervised and self-directed exercise sessions over 60 minutes BIW for up to 16 weeks. Patients also wear a FitBit daily over 16 weeks.
Receives: Behavioral: Exercise Intervention; Device: FitBit; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Atherosclerotic cardiovascular disease (ASCVD) 10-year risk score

    The 16-week exercise program would affect this risk score through reduction of systolic blood pressure (SBP) and cholesterol while increasing high-density lipoprotein (HDL).

    • A 0 to 4.9 percent risk is considered low. Eating a healthy diet and exercising will help keep your risk low.

    Medication is not recommended unless your LDL, or "bad" cholesterol, is greater than or equal to 190.

    • A 5 to 7.4 percent risk is considered borderline. Use of a statin medication may be recommended if you have certain conditions, or "risk enhancers." These conditions may increase your risk of a heart disease or stroke. Talk with your primary care provider to see if you have any of the risk enhancers in the list below.
    • A 7.5 to 20 percent risk is considered intermediate. It is recommended that you start with moderate-intensity statin therapy.
    • A greater than 20 percent risk is considered high. It is recommended that you start with high-intensity statin therapy

    Measured: Through the study completion, an average of a year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2021
  2. Study start23 Mar 2020
  3. Primary completion2 Feb 2027 (estimated)
  4. Study completion2 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05054296
Sponsor's protocol ID
2018-0938
Other IDs
NCI-2019-08624, 2018-0938
Status last verified
Mar 2023
First submitted
6 Jan 2020
Last updated
29 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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