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

About This Trial

This study is testing whether a 12-week home exercise program—either walking or riding a stationary bicycle—can improve strength and fitness for men with prostate cancer that has spread to other areas of the body.
It is designed for patients who are newly starting standard hormone therapy medications and have their doctor's approval to safely work out.
Participants will follow one of the exercise plans at home while the study team monitors their progress remotely.
Before considering this study, you should know that you will need to visit the clinic for initial training and fitness tests before and after the program, as well as complete regular surveys about your health.

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.

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study is testing whether a 12-week home exercise program—either walking or riding a stationary bicycle—can improve strength and fitness for men with prostate cancer that has spread to other areas of the body.

Full Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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 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