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Exercise for Tumor Suppressive Impact in Men With Prostate Cancer at High-Risk of Progression on Active Surveillance: The REMOVE Trial

NCT05918263 · Fred Hutchinson Cancer Center
In plain English

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About this study
This research study is a randomized controlled study for a home-based, virtually supervised, aerobic exercise intervention for men with prostate cancer at high-risk of progression undergoing active surveillance. There is evidence that exercise may suppress cancer progression, but the evidence is preliminary. Participants will be randomized into one of two treatment groups: Group A: Aerobic high-intensity interval training (HIIT) versus Group B: Waitlist Control. Randomization means a participant is placed into a study group by chance. The research study procedures include screening for eligibility, study treatment visits, survey questionnaires, blood tests, and follow-up visits. Participation in this research study is expected to last about 14 weeks. It is expected that about 68 people will take part in this research study. The Prostate Cancer Foundation is providing funding for this research study.
Eligibility criteria
Inclusion Criteria: * Age ≥18 years. * Histologically diagnosed with localized prostate cancer. * Initiating or undergoing active surveillance. * Having a higher risk of progression, defined as meeting one or more of the following: (1) favorable- intermediate risk prostate tumor at diagnosis, (2) obesity (body mass index ≥ 30), and/or (3) self- identified as Black or African American. * No plans for invasive treatment for their prostate cancer in the 12 weeks following the time of enrollment. * Ability to understand and willingness to provide informed consent. Exclusion Criteria: * Received any invasive curative-intent treatment for prostate cancer, including surgery, chemotherapy, radiation therapy, and hormonal therapy. * Patients with metastasis and/or other active malignancies (except basal cell carcinoma) and/or receiving treatment for those malignancies. * Participating in any (\>0 min/week) high-intensity exercise at the time of recruitment. * Having chronic medical conditions that are clinically unstable or uncontrolled with medications, deemed high-risk for exercise. These include but are not limited to unstable cardiac diseases, uncontrolled diabetes, and bone metastases with imminent risk of fracture. * Having a high risk for noncompliance with study procedures. This will be determined by the study team based on the history of missed oncology appointments (i.e., ≥3 no-shows in 6 months) and poor responsiveness during recruitment (i.e., ≥3 unreturned contacts). * Patients who are non-English speaking and unable to complete the participant surveys.
Study design
Enrollment target: 68 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-01-01
Estimated completion: 2027-03-31
Last updated: 2026-07-15
Interventions
Behavioral: High-Intensity Interval Training Exercise ProgramBehavioral: High-Intensity Interval Training Exercise Program
Primary outcomes
  • Prostate-Specific Antigen (PSA) Level (Baseline (Week 1) and post-intervention (Week 14))
Sponsor
Fred Hutchinson Cancer Center · other
With: Prostate Cancer Foundation
Contacts & investigators
ContactDong-Woo Kang, PhD · contact · dkang@fredhutch.org · 206-667-5188
InvestigatorDong-Woo Kang, PhD · principal_investigator, Fred Hutch/University of Washington Cancer Consortium
All locations (4)
Beth Israel Deaconess Medical CenterCompleted
Boston, Massachusetts, United States
Brigham and Women's HospitalCompleted
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteCompleted
Boston, Massachusetts, United States
Fred Hutch/University of Washington Cancer ConsortiumRecruiting
Seattle, Washington, United States
Exercise for Tumor Suppressive Impact in Men With Prostate Cancer at High-Risk of Progression on Active Surveillance: The REMOVE Trial · TrialPath