Exercise for Tumor Suppressive Impact in Men With Prostate Cancer at High-Risk of Progression on Active Surveillance: The REMOVE Trial
Recruiting · NCT05918263 · Interventional (participants receive a specific treatment) · Lead sponsor: Fred Hutchinson Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
High-Intensity Interval Training Exercise Program
What this trial is about
The purpose of this study is to determine whether a 12-week, home-based, virtually supervised exercise program will slow cancer progression of prostate cancer among men with prostate cancer at high-risk of progression undergoing active surveillance. The name of the study intervention involved in this study is: Aerobic high-intensity interval training (HIIT) (training exercise intervention)
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
4 locations listed across 2 US states.
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Fred Hutch/University of Washington Cancer Consortium - Seattle, Washington, United States