Castrate Sensitive Prostate CancerNCT06429813
Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)
A study testing Home-Based Exercise Intervention - Walking and Home-Based Exercise Intervention - HIIT Cycling in people with Castrate Sensitive Prostate Cancer and Metastatic Prostate Cancer, run by Paul Viscuse at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castrate Sensitive Prostate Cancer, Metastatic Prostate Cancer
- What is being tested?
- Home-Based Exercise Intervention - Walking and Home-Based Exercise Intervention - HIIT Cycling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christine Martin contact
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Steven Goff, 434-806-1357, WRS9HW@uvahealth.org
About this study
Official title: A Feasibility Study to Examine the Impact of Remotely Monitored Exercise Interventions on Cardiorespiratory/Muscular Fitness and Fatigue in Patients With Metastatic Castrate-sensitive Prostate Cancer (mCSPC) Undergoing Treatment With Androgen-deprivation Therapy (ADT) Intensification
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.
Read the detailed description
The purpose of this study is to find out how many patients who are being treated for mCSPC complete one of two home-based exercise programs. The researchers want to find out how much exercise participants complete and how satisfied they are with the program. Another purpose of this study is to learn if doing the exercise changes fitness levels and/or muscle strength, and what relationship those changes might have on feeling tired during cancer treatment.
Participants will be randomly assigned (like the flip of a coin) to one of two home-based exercise programs:
- Arm A: A high intensity interval (HIIT) stationary bike program
- Arm B: A walking program
Participants in the cycling group (Arm A) will receive a stationary exercise bike for home exercise. All participants in the study (Arms A and B) will receive an activity monitor (watch) and a heart rate-monitoring chest strap that sends information back to the study team.
Participants will receive 1-2 exercise training sessions, held in a UVA research lab, to allow them to experience the level of the exercise they will be asked to complete. Each participant will make a personal plan with the study team to gradually workup to the exercise goal assigned to each group. The research team will answer any questions and help set up the activity monitors. After these session(s), the remaining 12 weeks of exercise will occur at home.
- Being tested
- Home-Based Exercise Intervention - Walking, Home-Based Exercise Intervention - HIIT Cycling
- Keywords
- prostate, metastatic prostate cancer, metastatic castrate-sensitive prostate cancer, prostate cancer, exercise, ADT, ARSI
- Medical subject headings
- Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Exercise Intervention - WalkingBehavioural
30 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 CyclingBehavioural
Four, 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
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | HIIT Cycling Intervention Receives: Behavioral: Home-Based Exercise Intervention - HIIT Cycling |
| Arm B | Experimental | Walking Intervention Receives: Behavioral: Home-Based Exercise Intervention - Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete the post-intervention follow-up assessment
Percentage of participants who complete the post-intervention follow-up assessment
Measured: 14 weeks from the start of the intervention
Secondary outcomes (6)
Treatment engagement with intervention
Frequency, intensity and duration of exercise as measured by the activity monitors.
Measured: From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
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.
Measured: From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
Patient-reported outcomes on exercise
Exit interviews include open and closed ended questions about the participant's experience in the study.
Measured: From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
Rate of recruitment per month
Number of individuals screened and randomized
Measured: Each month for 12 months (estimated duration of accrual of participants)
Physical fitness (Cardiorespiratory)
As measured by VO2 peak
Measured: Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later)
Muscular strength (quadriceps)
Isometric and isokinetic torque in multiple positions (e.g. 60-120 degrees)
Measured: Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start26 Jul 2024
- Primary completionAug 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castrate Sensitive Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul Viscuse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Viscuse, University of Virginia
- Investigators
- Paul Viscuse, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429813
- Sponsor's protocol ID
- HSR230542
- Status last verified
- Apr 2026
- First submitted
- 14 May 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Examine the Impact of Remotely Monitored Exercise Interventions on Cardiorespiratory/Muscular Fitness and Fatigue in Patients With Metastatic Castrate-sensitive Prostate Cancer (mCSPC) Undergoing Treatment With Androgen-deprivation Therapy (ADT) Intensification
- ClinicalTrials.gov ID
- NCT06429813
- Acronym / sponsor ID
- HSR230542
- Keywords
- prostate, metastatic prostate cancer, metastatic castrate-sensitive prostate cancer, prostate cancer, exercise, ADT, ARSI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Paul ViscuseUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to find out how many patients who are being treated for mCSPC complete one of two home-based exercise programs. The researchers want to find out how much exercise participants complete and how satisfied they are with the program. Another purpose of this study is to learn if doing the exercise changes fitness levels and/or muscle strength, and what relationship those changes might have on feeling tired during cancer treatment.
Participants will be randomly assigned (like the flip of a coin) to one of two home-based exercise programs:
- Arm A: A high intensity interval (HIIT) stationary bike program
- Arm B: A walking program
Participants in the cycling group (Arm A) will receive a stationary exercise bike for home exercise. All participants in the study (Arms A and B) will receive an activity monitor (watch) and a heart rate-monitoring chest strap that sends information back to the study team.
Participants will receive 1-2 exercise training sessions, held in a UVA research lab, to allow them to experience the level of the exercise they will be asked to complete. Each participant will make a personal plan with the study team to gradually workup to the exercise goal assigned to each group. The research team will answer any questions and help set up the activity monitors. After these session(s), the remaining 12 weeks of exercise will occur at home.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Behavioral: Home-Based Exercise Intervention - HIIT CyclingHIIT Cycling Intervention |
| Arm B | Experimental | Behavioral: Home-Based Exercise Intervention - WalkingWalking Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-Based Exercise Intervention - Walking30 minutes of walking or light jogging a day at a moderate intensity for 30 minutes a day, 5 days a week for 12 weeks | Behavioural | Arm B |
| Home-Based Exercise Intervention - HIIT CyclingFour, 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 | Behavioural | Arm A |
Primary outcome
Number of participants who complete the post-intervention follow-up assessment
Time frame: 14 weeks from the start of the intervention
Percentage of participants who complete the post-intervention follow-up assessment
6 secondary outcomes
Treatment engagement with intervention
Time frame: From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
Acceptability of exercise
Time frame: From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
Patient-reported outcomes on exercise
Time frame: From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
Rate of recruitment per month
Time frame: Each month for 12 months (estimated duration of accrual of participants)
Physical fitness (Cardiorespiratory)
Time frame: Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later)
Muscular strength (quadriceps)
Time frame: Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
Related trials for Castrate Sensitive Prostate Cancer
Active, not recruitingPhase 3
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
Metastatic Castrate-sensitive Prostate Cancer
Active, not recruitingPhase 2
Focal Radiation With Pulsed Systemic Therapy of Abiraterone, Androgen Deprivation Therapy (ADT), Lynparza Towards Castration Sensitive Oligometastatic Prostate Cancer (FAALCON)
Prostate Cancer, Castrate Sensitive Prostate Cancer
RecruitingPhase 2
Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.
Metastatic Cancer, Neoplasm, Prostate
RecruitingObservational study
PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer
Prostate Cancer, Metastatic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Martin contact
Paul Viscuse, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based Exercise Intervention - Walking and Home-Based Exercise Intervention - HIIT Cycling in people with Castrate Sensitive Prostate Cancer and Metastatic Prostate Cancer, run by Paul Viscuse at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven Goff (434-806-1357, WRS9HW@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who complete the post-intervention follow-up assessment (time frame: 14 weeks from the start of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.