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

Korábbi kezelés

• 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
• Unstable angina or myocardial infarction within 4-weeks prior to treatment
• 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

Más betegség

• Significant cardiac/renal/hepatic/hematological/pulmonary disease precluding exercise training
• Complex ventricular arrhythmias or New York Heart Association class IV symptoms
• Recent retinal hemorrhage
• Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 120 mm Hg)
• Symptomatic peripheral vascular disease

Laborértékek

• 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)

Egyéb

• 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
• Symptomatic severe aortic stenosis
• Acute pulmonary embolus
• Acute myocarditis
• Untreated high-risk proliferative retinopathy

• 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.