Home-based exercise programs for men with metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates two home-based exercise programs for men diagnosed with metastatic castrate-sensitive prostate cancer (mCSPC) who are starting androgen deprivation therapy. Participants will be randomly assigned to either a high-intensity interval training (HIIT) cycling program or a walking program, with the goal of assessing their exercise completion rates and satisfaction. The study includes pre- and post-exercise fitness assessments and questionnaires to measure changes in fitness levels, muscle strength, and fatigue during cancer treatment. The exercise intervention lasts for 12 weeks, with initial training sessions conducted at the University of Virginia.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Paul Viscuse, MD — University of Virginia
• Study coordinator: Steven Goff
• Email: WRS9HW@uvahealth.org
• Phone: 434-806-1357

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.