Clinical Trials Logo

Clinical 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 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06429813
Study type Interventional
Source University of Virginia
Contact Steven Goff
Phone 434-806-1357
Email WRS9HW@uvahealth.org
Status Not yet recruiting
Phase N/A
Start date July 2024
Completion date November 2025

See also
  Status Clinical Trial Phase
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Recruiting NCT04533958 - Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy N/A
Not yet recruiting NCT06009549 - A Journey Into Participation Patterns Among Metastatic Prostate Cancer Patients
Withdrawn NCT05771896 - Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC Phase 3
Completed NCT01981122 - A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer Phase 2
Completed NCT01233557 - Biomarkers of Bone Resorption in Metastatic Prostate Cancer N/A
Completed NCT01012141 - Docetaxel With a Phytochemical in Treating Patients With Hormone Independent Metastatic Prostate Cancer Phase 2
Recruiting NCT04067713 - Plasma Analysis for Response Assessment and to DIrect the manaGement of Metastatic Prostate Cancer
Active, not recruiting NCT04332744 - Enzalutamide Plus Talazoparib for the Treatment of Hormone Sensitive Prostate Cancer (ZZ-First) Phase 2
Completed NCT04545697 - mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer N/A
Recruiting NCT04140526 - Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC Phase 1/Phase 2
Not yet recruiting NCT04031378 - Single Dose Radiotherapy (SDRT) With or Without Adjuvant Systemic Therapy for Oligometastatic Prostate Cancer Phase 2
Completed NCT02278055 - Non-Randomized Trial Assessing Pain Efficacy With Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer Phase 2
Completed NCT04193657 - Toward a Comprehensive Supportive Care Intervention for Older or Frail Men With mCRPC
Completed NCT02260817 - Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer Phase 3
Terminated NCT00216060 - Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy Phase 3
Recruiting NCT04070209 - Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X) Phase 2
Recruiting NCT04925648 - Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction Phase 2
Completed NCT01303705 - Anti-OX40, Cyclophosphamide (CTX) and Radiation in Patients With Progressive Metastatic Prostate Cancer Phase 1