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

Recruiting now · Not applicable

Conditions studied: Castrate Sensitive Prostate Cancer, Metastatic Prostate Cancer

In brief

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.

Key facts

Study ID

NCT06429813

Run by

Paul Viscuse

People needed

24

Starts

2024-07-26

Expected to finish

2027-11-01

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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)
• Symptomatic peripheral vascular disease
• Prior treatment with taxane- or platinum- based chemotherapy
• Prior treatment with PARP [Poly (ADP-ribose) polymerase] inhibitors
• Prior treatment with radium-223 or lutetium-177

Where it is running

• University of Virginia — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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