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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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
COMPLETED
Boston
Brigham and Women's Hospital
COMPLETED
Boston
Dana-Farber Cancer Institute
COMPLETED
Boston
Washington
Fred Hutch/University of Washington Cancer Consortium
RECRUITING
Seattle
Contact Information
Primary
Dong-Woo Kang, PhD
dkang@fredhutch.org
206-667-5188
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 68
Treatments
Experimental: Group A: HIIT Exercise Program
Participants will be allocated in a 1:1 ratio, using a permuted blocked design with varying block size. Study procedures will be conducted as follows:~* Testing visits at Week 1 and 14 for physical exams, physical fitness and function assessments, survey questionnaires, and cardiopulmonary fitness assessment.~* Virtual, aerobic training sessions three times weekly with trained oncology exercise specialist.
Experimental: Group B: Waitlist Control
Participants will be allocated in a 1:1 ratio, using a permuted blocked design with varying block size. Study procedures will be conducted as follows:~* Testing visits at Week 1 and 14 for physical exams, physical fitness and function assessments, and survey questionnaires.~* Upon completion of post-intervention assessments, participants will have the option to take part in the 12-week HIIT exercise program.
Related Therapeutic Areas
Sponsors
Collaborators: Prostate Cancer Foundation
Leads: Fred Hutchinson Cancer Center

This content was sourced from clinicaltrials.gov