NCT06429813 Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)
| NCT ID | NCT06429813 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Paul Viscuse |
| Condition | Castrate Sensitive Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-07-26 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2024-07-26 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male, aged ≥18 years old 4. 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) 5. 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. 6. Planned intensification with ARSI (abiraterone/prednisone, enzalutamide, apalutamide, or darolutamide). 7. Oncologist clearance for exercise training after taking into account functional status and co-morbid conditions that may limit ability to participate. 8. Ability to take oral medication and willing to adhere to the study intervention regimen 9. Ability to read, speak, and understand English. Exclusion Criteria: 1. 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) 2. 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 3. Metastatic bone lesion(s) in the proximal femur, bone lesion causing impending fracture, or other metastatic site deemed unsafe for walking by treating physician 4. Medical/orthopedic comorbidities that preclude stationary cycling or walking 5. Significant cardiac/renal/hepatic/hematological/pulmonary disease precluding exercise training 6. Unstable angina or myocardial infarction within 4-weeks prior to treatment 7. Complex ventricular arrhythmias or New York Heart Association class IV symptoms 8. Symptomatic severe aortic stenosis 9. Acute pulmonary embolus 10. Acute myocarditis 11. Untreated high-risk proliferative retinopathy 12. Recent retinal hemorrhage 13. Uncontrolled hypertension (systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 120 mm Hg) 14. Severe baseline electrolyte abnormalities (e.g. potassium) that may predispose patient to arrhythmias in the opinion of the treating investigator 15. Uncontrolled metabolic disease (diabetes with fasting blood sugar \>300 mg/dl, thyrotoxicosis, myxedema) 16. Symptomatic peripheral vascular disease 17. Prior treatment with taxane- or platinum- based chemotherapy 18. Prior treatment with PARP \[Poly (ADP-ribose) polymerase\] inhibitors 19. Prior treatment with radium-223 or lutetium-177
Contact & Investigator
Paul Viscuse, MD
PRINCIPAL INVESTIGATOR
University of Virginia
Frequently Asked Questions
Who can join the NCT06429813 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Castrate Sensitive Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06429813 currently recruiting?
Yes, NCT06429813 is actively recruiting participants. Contact the research team at WRS9HW@uvahealth.org for enrollment information.
Where is the NCT06429813 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT06429813 clinical trial?
NCT06429813 is sponsored by Paul Viscuse. The principal investigator is Paul Viscuse, MD at University of Virginia. The trial plans to enroll 24 participants.
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