Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorPaul Viscuse
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Home-Based Exercise Intervention - Walking
Behavioral30 minutes of walking or light jogging a day at a moderate intensity for 30 minutes a day, 5 days a week for 12 weeks
Home-Based Exercise Intervention - HIIT Cycling
BehavioralFour, 4 minute high intensity intervals of exercise, separated by 3 minutes of lower intensity exercise + a 10 minute warm up and 5 minute cool down for 40 minutes a day, 3 days a week for 12 weeks
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Arm AExperimental treatment 1 intervention
Group B: Arm BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants who complete the post-intervention follow-up assessment
Percentage of participants who complete the post-intervention follow-up assessment
Time frame
14 weeks from the start of the interventionSecondary outcomes
1
Treatment engagement with intervention
Frequency, intensity and duration of exercise as measured by the activity monitors.
Time frame
From the beginning of the intervention to the Post-intervention visit (about 12 weeks)2
Acceptability of exercise
The Physical Activity Enjoyment Scale (PACES) is an 18 question, 7 point scale that includes questions regarding enjoyment of physical activity in the study.
Time frame
From the beginning of the intervention to the Post-intervention visit (about 12 weeks)3
Patient-reported outcomes on exercise
Exit interviews include open and closed ended questions about the participant's experience in the study.
Time frame
From the beginning of the intervention to the Post-intervention visit (about 12 weeks)4
Rate of recruitment per month
Number of individuals screened and randomized
Time frame
Each month for 12 months (estimated duration of accrual of participants)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Paul Viscuse
Lead sponsor
University of Virginia
Sponsor institution
Source ClinicalTrials.gov