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

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

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)

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.

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.