Recruiting
Phase 2

Risk Factor Modification

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05054296

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

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Educational Intervention

Exercise Intervention

FitBit

Quality-of-Life Assessment

Questionnaire Administration

Study Details

Brief 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 (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

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

Study ID

NCT05054296

Start date

Mar 23, 2020

Status verified date

Mar, 2023

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Group I (education exercise packet, FitBit)

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.

experimental: Group II (exercise program FitBit)

Patients 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.

Interventions

Educational Intervention

Receive general education exercise packet

Exercise Intervention

Participate in supervised and self-directed exercise sessions

FitBit

Wear FitBit for activity tracking

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Atherosclerotic cardiovascular disease (ASCVD) 10-year risk score [ Time Frame: Through the study completion, an average of a year. ]

Central Contacts and Locations

Central contacts

Christopher J Logothetis

7135637210clogothe@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Christopher J. Logothetis

713-792-2830

Principal Investigator:

Christopher J. Logothetis

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Mar 29, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2023-03-29.