RecruitingNot ApplicableNCT06429813

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

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


Sponsor

Paul Viscuse

Enrollment

24 participants

Start Date

Jul 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a remotely monitored exercise program can help men with metastatic prostate cancer who are on hormone therapy (ADT) maintain their strength, physical function, and quality of life. Hormone therapy often causes muscle loss, fatigue, and metabolic changes that exercise may help counter. **You may be eligible if...** - You are a man aged 18 or older - You have been diagnosed with metastatic prostate cancer (cancer that has spread beyond the prostate) - You are starting or continuing hormone therapy (ADT/LHRH therapy) for your prostate cancer - You have not yet progressed to castrate-resistant disease **You may NOT be eligible if...** - Your prostate cancer is castrate-resistant (meaning it continues to grow despite hormone therapy that has reduced testosterone to very low levels) - Your prostate cancer has an elevated PSA after prior treatment but imaging shows no metastases (biochemical recurrence without spread) - You have bone metastases that make exercise unsafe - You have other serious conditions that would prevent safe participation in exercise Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALHome-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

BEHAVIORALHome-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


Locations(1)

University of Virginia

Charlottesville, Virginia, United States

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NCT06429813


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