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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

RECRUITINGN/ASponsored by Fred Hutchinson Cancer Center
Actively Recruiting
PhaseN/A
SponsorFred Hutchinson Cancer Center
Started2024-01-01
Est. completion2027-03-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations4 sites

Summary

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)

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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.

Conditions3

CancerProstate CancerProstatic Neoplasms

Locations4 sites

Massachusetts

3 sites
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute

Washington

1 site
Fred Hutch/University of Washington Cancer Consortium
Dong-Woo Kang, PhD206-667-5188dkang@fredhutch.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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