Recruiting

Exercise Interventions

Sponsor:

Paul Viscuse

Code:

NCT06429813

Conditions

Castrate Sensitive Prostate Cancer

Metastatic Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Home-Based Exercise Intervention - Walking

Home-Based Exercise Intervention - HIIT Cycling

Study Details

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

Study ID

NCT06429813

Start date

Jul 26, 2024

Status verified date

Apr, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm A

HIIT Cycling Intervention

experimental: Arm B

Walking Intervention

Interventions

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

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

Primary outcome measure

  • Number of participants who complete the post-intervention follow-up assessment [ Time Frame: 14 weeks from the start of the intervention ]

Central Contacts and Locations

Central contacts

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

More Information

Sponsor

Paul Viscuse

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Paul Viscuse on 2026-05-04.