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

NCT06429813 | Recruiting DMC

• 1 other identifier: HSR230542
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Castrate Sensitive Prostate Cancer; Metastatic Prostate Cancer

Keywords

prostate; metastatic prostate cancer; metastatic castrate-sensitive prostate cancer; prostate cancer; exercise; ADT; ARSI

Outcome Measures

Primary Outcomes (1)

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

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

  14 weeks from the start of the intervention

Secondary Outcomes (6)

• Treatment engagement with intervention

  From the beginning of the intervention to the Post-intervention visit (about 12 weeks)

• Acceptability of exercise

  From the beginning of the intervention to the Post-intervention visit (about 12 weeks)

• Patient-reported outcomes on exercise

  From the beginning of the intervention to the Post-intervention visit (about 12 weeks)

• Rate of recruitment per month

  Each month for 12 months (estimated duration of accrual of participants)

• Physical fitness (Cardiorespiratory)

  Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later)

Study Arms (2)

Arm A

EXPERIMENTAL

HIIT Cycling Intervention

Behavioral: Home-Based Exercise Intervention - HIIT Cycling

Arm B

EXPERIMENTAL

Walking Intervention

Behavioral: Home-Based Exercise Intervention - Walking

Interventions

Home-Based Exercise Intervention - Walking BEHAVIORAL

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

Arm B

Home-Based Exercise Intervention - HIIT Cycling BEHAVIORAL

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

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male, aged ≥18 years old
• 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)
• 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.
• Planned intensification with ARSI (abiraterone/prednisone, enzalutamide, apalutamide, or darolutamide).
• Oncologist clearance for exercise training after taking into account functional status and co-morbid conditions that may limit ability to participate.
• Ability to take oral medication and willing to adhere to the study intervention regimen
• Ability to read, speak, and understand English.

You may not qualify if:

• 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)
• 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
• Metastatic bone lesion(s) in the proximal femur, bone lesion causing impending fracture, or other metastatic site deemed unsafe for walking by treating physician
• Medical/orthopedic comorbidities that preclude stationary cycling or walking
• Significant cardiac/renal/hepatic/hematological/pulmonary disease precluding exercise training
• Unstable angina or myocardial infarction within 4-weeks prior to treatment
• Complex ventricular arrhythmias or New York Heart Association class IV symptoms
• Symptomatic severe aortic stenosis
• Acute pulmonary embolus
• Acute myocarditis
• Untreated high-risk proliferative retinopathy
• Recent retinal hemorrhage
• Uncontrolled hypertension (systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 120 mm Hg)
• Severe baseline electrolyte abnormalities (e.g. potassium) that may predispose patient to arrhythmias in the opinion of the treating investigator
• Uncontrolled metabolic disease (diabetes with fasting blood sugar \>300 mg/dl, thyrotoxicosis, myxedema)

Sponsors & Collaborators

• Paul Viscuse: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Paul Viscuse, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Goff

CONTACT

434-806-1357; WRS9HW@uvahealth.org

Christine Martin

CONTACT

CMP2P@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 28, 2024
• Study Start: July 26, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)