Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)

April 27, 2026 updated by: Paul Viscuse

A Feasibility Study to Examine the Impact of Remotely Monitored Exercise Interventions on Cardiorespiratory/Muscular Fitness and Fatigue in Patients With Metastatic Castrate-sensitive Prostate Cancer (mCSPC) Undergoing Treatment With Androgen-deprivation Therapy (ADT) Intensification

This study consists of two home-based exercise programs: a stationary exercise bicycle intervention (Arm A), and a walking intervention (Arm B). The study will enroll 24 patients who are starting ADT (Androgen Deprivation Therapy)/ARSI (Androgen-Receptor Signaling Inhibitors) therapy for newly diagnosed metastatic castrate-sensitive prostate cancer (mCSPC). All participants will be asked to complete 1-2 training sessions at UVA prior to starting the exercise. All participants will be asked to complete aerobic and strength testing before and after the exercise program. Participants will be asked to answer questionnaires throughout the program. The at-home exercise will last for 12 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to find out how many patients who are being treated for mCSPC complete one of two home-based exercise programs. The researchers want to find out how much exercise participants complete and how satisfied they are with the program. Another purpose of this study is to learn if doing the exercise changes fitness levels and/or muscle strength, and what relationship those changes might have on feeling tired during cancer treatment.

Participants will be randomly assigned (like the flip of a coin) to one of two home-based exercise programs:

  • Arm A: A high intensity interval (HIIT) stationary bike program
  • Arm B: A walking program

Participants in the cycling group (Arm A) will receive a stationary exercise bike for home exercise. All participants in the study (Arms A and B) will receive an activity monitor (watch) and a heart rate-monitoring chest strap that sends information back to the study team.

Participants will receive 1-2 exercise training sessions, held in a UVA research lab, to allow them to experience the level of the exercise they will be asked to complete. Each participant will make a personal plan with the study team to gradually workup to the exercise goal assigned to each group. The research team will answer any questions and help set up the activity monitors. After these session(s), the remaining 12 weeks of exercise will occur at home.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male, aged ≥18 years old
  4. Diagnosis of mCSPC (defined as either biopsy-proven metastatic prostate cancer or elevated PSA (Prostate Specific Antigen) in the setting of imaging findings typical of prostate cancer spread; patients can either have de novo metastatic disease or recurrent metastatic disease after prior definitive therapy to the primary tumor with either surgery or radiation)
  5. Planned treatment with ADT (LHRH [Luteinizing hormone-releasing hormone] agonist such as leuprolide or LHRH antagonist such as degarelix), or recent administration, ≤14 days prior to enrollment.
  6. Planned intensification with ARSI (abiraterone/prednisone, enzalutamide, apalutamide, or darolutamide).
  7. Oncologist clearance for exercise training after taking into account functional status and co-morbid conditions that may limit ability to participate.
  8. Ability to take oral medication and willing to adhere to the study intervention regimen
  9. Ability to read, speak, and understand English.

Exclusion Criteria:

  1. Castrate-resistant prostate cancer (defined as prostate cancer previously treated with a backbone of ADT hormonal therapy with either progression of disease on imaging PSA progression with PSA increase of > 25% and 2 ng/mL above nadir, confirmed at 2 time points at least 3 weeks apart, in the setting of testosterone level < 50)
  2. Patients with prostate cancer with biochemical recurrence (e.g., received prior definitive therapy with subsequent PSA [Prostate-Specific Antigen] rise) but radiographic imaging is negative for metastatic disease
  3. Metastatic bone lesion(s) in the proximal femur, bone lesion causing impending fracture, or other metastatic site deemed unsafe for walking by treating physician
  4. Medical/orthopedic comorbidities that preclude stationary cycling or walking
  5. Significant cardiac/renal/hepatic/hematological/pulmonary disease precluding exercise training
  6. Unstable angina or myocardial infarction within 4-weeks prior to treatment
  7. Complex ventricular arrhythmias or New York Heart Association class IV symptoms
  8. Symptomatic severe aortic stenosis
  9. Acute pulmonary embolus
  10. Acute myocarditis
  11. Untreated high-risk proliferative retinopathy
  12. Recent retinal hemorrhage
  13. Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 120 mm Hg)
  14. Severe baseline electrolyte abnormalities (e.g. potassium) that may predispose patient to arrhythmias in the opinion of the treating investigator
  15. Uncontrolled metabolic disease (diabetes with fasting blood sugar >300 mg/dl, thyrotoxicosis, myxedema)
  16. Symptomatic peripheral vascular disease
  17. Prior treatment with taxane- or platinum- based chemotherapy
  18. Prior treatment with PARP [Poly (ADP-ribose) polymerase] inhibitors
  19. Prior treatment with radium-223 or lutetium-177

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
HIIT Cycling Intervention
Behavioral: Home-Based Exercise Intervention - HIIT Cycling
Four, 4 minute high intensity intervals of exercise, separated by 3 minutes of lower intensity exercise + a 10 minute warm up and 5 minute cool down for 40 minutes a day, 3 days a week for 12 weeks
Experimental: Arm B
Walking Intervention
Behavioral: Home-Based Exercise Intervention - Walking
30 minutes of walking or light jogging a day at a moderate intensity for 30 minutes a day, 5 days a week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who complete the post-intervention follow-up assessment
Time Frame: 14 weeks from the start of the intervention
Percentage of participants who complete the post-intervention follow-up assessment
14 weeks from the start of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment engagement with intervention
Time Frame: From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
Frequency, intensity and duration of exercise as measured by the activity monitors.
From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
Acceptability of exercise
Time Frame: From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
The Physical Activity Enjoyment Scale (PACES) is an 18 question, 7 point scale that includes questions regarding enjoyment of physical activity in the study.
From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
Patient-reported outcomes on exercise
Time Frame: From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
Exit interviews include open and closed ended questions about the participant's experience in the study.
From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
Rate of recruitment per month
Time Frame: Each month for 12 months (estimated duration of accrual of participants)
Number of individuals screened and randomized
Each month for 12 months (estimated duration of accrual of participants)
Physical fitness (Cardiorespiratory)
Time Frame: Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later)
As measured by VO2 peak
Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later)
Muscular strength (quadriceps)
Time Frame: Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later
Isometric and isokinetic torque in multiple positions (e.g. 60-120 degrees)
Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul Viscuse

Investigators

  • Principal Investigator: Paul Viscuse, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR230542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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