Actively Recruiting
Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)
Led by Paul Viscuse · Updated on 2026-05-04
24
Participants Needed
1
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to follow all study procedures and be available for the entire study
- Male, aged 18 years or older
- Diagnosis of metastatic castrate-sensitive prostate cancer (mCSPC) confirmed by biopsy or typical imaging and PSA levels
- Planned or recent start (within 14 days) of androgen deprivation therapy (ADT)
- Planned treatment intensified with androgen-receptor signaling inhibitors (ARSI) such as abiraterone, enzalutamide, apalutamide, or darolutamide
- Clearance from oncologist to participate in exercise considering functional status and other health conditions
- Ability to take oral medication and follow the study treatment plan
- Ability to read, speak, and understand English
You will not qualify if you...
- Castrate-resistant prostate cancer with disease progression despite ADT
- Prostate cancer with biochemical recurrence but no detectable metastatic disease on imaging
- Metastatic bone lesions in the proximal femur or lesions unsafe for walking
- Medical or orthopedic issues preventing cycling or walking exercise
- Serious heart, kidney, liver, blood, or lung diseases that stop exercise
- Recent unstable angina or heart attack within 4 weeks before treatment
- Severe heart rhythm problems or advanced heart failure symptoms
- Severe aortic valve narrowing
- Acute pulmonary embolus or myocarditis
- Untreated high-risk eye disease or recent retinal bleeding
- Uncontrolled high blood pressure (systolic >180 or diastolic >120 mm Hg)
- Severe electrolyte imbalances increasing risk of arrhythmias
- Uncontrolled metabolic diseases like very high blood sugar or thyroid problems
- Symptomatic peripheral vascular disease
- Previous treatment with taxane- or platinum-based chemotherapy
- Previous treatment with PARP inhibitors
- Previous treatment with radium-223 or lutetium-177
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
S
Steven Goff
CONTACT
C
Christine Martin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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