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Behavioural Intervention

Home-Based Exercise for Prostate Cancer

N/A

Recruiting

Led By Paul Viscuse, MD

Research Sponsored by Paul Viscuse

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned treatment with ADT (LHRH agonist such as leuprolide or LHRH antagonist such as degarelix), and intensification with ARSI (abiraterone/prednisone, enzalutamide, apalutamide, or darolutamide)

Male, aged ≥18 years old

Must not have

Metastatic bone lesion(s) in the proximal femur, bone lesion causing impending fracture, or other metastatic site deemed unsafe for walking by treating physician

Uncontrolled metabolic disease (diabetes with fasting blood sugar >300 mg/dl, thyrotoxicosis, myxedema)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later

Awards & highlights

Summary

This trial involves two different exercise programs that can be done at home: one using a stationary exercise bike (Arm A) and the other involving walking (Arm B). The study will include 24 patients

Who is the study for?

This trial is for patients with newly diagnosed metastatic castrate-sensitive prostate cancer (mCSPC) who are starting ADT/ARSI therapy. Participants will need to complete training at UVA and be able to do aerobic and strength testing before and after a 12-week home-based exercise program.

What is being tested?

The study tests two types of home-based exercise programs: one involving stationary cycling (HIIT Cycling), the other walking. The goal is to see how these exercises affect patients undergoing ADT/ARSI treatment for mCSPC over a period of 12 weeks.

What are the potential side effects?

Since this trial involves non-drug interventions like walking and cycling, side effects may include typical exercise-related issues such as muscle soreness, fatigue, or injury from physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for hormone therapy with additional advanced prostate cancer medication.

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I am a man aged 18 or older.

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I have prostate cancer that has spread, confirmed by biopsy or high PSA and imaging.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cancer spread to my bones that affects my ability to walk.

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I do not have uncontrolled diabetes or thyroid issues.

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I cannot cycle or walk due to other health issues.

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I have severe symptoms from a narrowed heart valve.

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I have had a recent blood clot in my lung.

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I have inflammation of the heart muscle.

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I have had a recent bleeding in my eye.

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I have been treated with taxane or platinum chemotherapy before.

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I have a severe form of retinopathy that hasn't been treated.

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My prostate cancer returned after treatment, but scans show no spread.

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I have been treated with PARP inhibitors before.

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My prostate cancer is resistant to hormonal therapy and has worsened despite treatment.

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I do not have major heart, kidney, liver, blood, or lung conditions that prevent me from exercising.

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I have severe heart symptoms or irregular heartbeats.

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I have symptoms from poor blood flow in my limbs.

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I have previously been treated with radium-223 or lutetium-177.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants who complete the post-intervention follow-up assessment

Secondary outcome measures

Acceptability of exercise

Muscular strength (quadriceps)

Patient-reported outcomes on exercise

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment1 Intervention

Walking Intervention

Group II: Arm AExperimental Treatment1 Intervention

HIIT Cycling Intervention

0 / 19Eligibility criteria met

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Who is running the clinical trial?

Paul ViscuseLead Sponsor

Paul Viscuse, MDPrincipal InvestigatorUniversity of Virginia

~16 spots leftby Nov 2025

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