Remotely Monitored Exercise Interventions in Patients with MCSPC Undergoing ADT (Prostate 006)

Launched by PAUL VISCUSE · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial, called Prostate 006, is studying two home-based exercise programs designed for men with newly diagnosed metastatic castrate-sensitive prostate cancer (mCSPC) who are starting hormone therapy. The trial will enroll 24 participants, who will either use a stationary exercise bicycle or focus on walking as their exercise method for 12 weeks. Before starting, all participants will attend 1-2 training sessions at the University of Virginia (UVA) to learn how to safely do their exercises, and they will complete tests to measure their aerobic fitness and strength both before and after the program. Throughout the study, participants will fill out questionnaires to provide feedback on their experience.

To be eligible for this trial, participants must be men aged 18 or older with a diagnosis of mCSPC and must be starting androgen deprivation therapy (a common treatment for prostate cancer). They should be cleared by their oncologist to participate in exercise and must be willing to follow the study’s guidelines. Participants will need to read, speak, and understand English, as study materials will be provided in English. This trial aims to see how exercise can help improve the health and well-being of men undergoing treatment for this type of cancer, so if you or someone you know fits the criteria, it might be a beneficial opportunity to consider.

Gender

MALE

Eligibility 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

Trial Officials