Home-based exercise programs for men with metastatic prostate cancer
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
This study is testing two different home exercise programs to see if they can help men with metastatic prostate cancer feel better while starting their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Virginia Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT06429813 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with a diagnosis of metastatic castrate-sensitive prostate cancer who are starting androgen deprivation therapy.
Not a fit: Patients who are not cleared for exercise training by their oncologist or those with severe co-morbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve physical fitness and reduce fatigue in patients undergoing treatment for metastatic prostate cancer.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in cancer patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Charlottesville, Virginia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.