What this study is
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)
What's being tested
- High-Intensity Interval Training Exercise Program
Intervention · BEHAVIORAL
Home-based, virtually supervised, aerobic exercise program of 36 sessions accessible via internet-enabled tablet (provided to participant if needed). Participants will be supplied with stationary bike, heart rate monitor, and blood pressure monitor.
- High-Intensity Interval Training Exercise Program
Intervention · BEHAVIORAL
(Optionally) Home-based, virtually supervised, aerobic exercise program of 36 sessions accessible via internet-enabled tablet (provided to participant if needed). Participants will be supplied with stationary bike, heart rate monitor, and blood pressure monitor.
Study details
- Sponsor
- Fred Hutchinson Cancer Center
- Conditions
- Prostate Cancer · Prostatic Neoplasms
- Enrolling
- 68 people
- Starts
- 2024-01-01
- Est. completion
- 2027-03-31
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex MALEHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
1 openFred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
- Dong-Woo Kang, PhD · Contact206-667-5188dkang@fredhutch.org
- Dong-Woo Kang, PhD · Principal investigator
RecruitingBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CompletedBrigham and Women's Hospital
Boston, Massachusetts, United States
CompletedDana-Farber Cancer Institute
Boston, Massachusetts, United States
Completed
Study team
Sponsor
Fred Hutchinson Cancer Center
Study ID RG1125288
Principal investigator
Dong-Woo Kang, PhD
Fred Hutch/University of Washington Cancer Consortium
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.