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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT05918263
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High-Intensity Interval Training Exercise Program — 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 — 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

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)

Key Dates

First listed
Jun 26, 2023
Start date
Jan 1, 2024
Status verified
Jul 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Prostate-Specific Antigen (PSA) Level [ Time Frame: Baseline (Week 1) and post-intervention (Week 14) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Dong-Woo Kang, PhD
[email protected]
206-667-5188
Dong-Woo Kang, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Beth Israel Deaconess Medical Center· Boston, MABrigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MAFred Hutch/University of Washington Cancer Consortium· Seattle, WA

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