Exercise for Tumor Suppressive Impact in Men With Prostate Cancer at High-Risk of Progression on Active Surveillance: The REMOVE Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 68
- Locations
- 4
- Primary Endpoint
- Prostate-Specific Antigen (PSA) Level
Study Overview
Brief 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)
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Masking Description
Principal investigator blinded to block size
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: High-Intensity Interval Training Exercise Program (Behavioral)
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.
Intervention: High-Intensity Interval Training Exercise Program (Behavioral)
Outcomes
Primary Outcomes
Prostate-Specific Antigen (PSA) Level
Time Frame: Baseline (Week 1) and post-intervention (Week 14)
The primary outcome is the between-group difference in prostate-specific antigen (PSA) levels post-intervention. Analysis of covariance will be used to detect the difference adjusting for baseline values of the outcome and other covariates.
Secondary Outcomes
- Prostate-Specific Antigen (PSA) Velocity(Baseline (Week 1) and post-intervention (Week 14))
- Prostate-Specific Antigen (PSA) Doubling Time(Baseline (Week 1) and post-intervention (Week 14))
- Proliferation of LNCaP Prostate Cancer Cell Line(Baseline (Week 1) and post-intervention (Week 14))
- Muscular Strength(Baseline (Week 1) and post-intervention (Week 14))
- Short Physical Performance Battery (SPPB)(Baseline (Week 1) and post-intervention (Week 14))
- Health-Related Quality of Life(Baseline (Week 1) and post-intervention (Week 14))
- Prostate Cancer-Specific Anxiety(Baseline (Week 1) and post-intervention (Week 14))
- Fear of Cancer Progression Assessment(Baseline (Week 1) and post-intervention (Week 14))
- Cardiorespiratory Fitness(Baseline (Week 1) and post-intervention (Week 14))
- Sleep Quality(Baseline (Week 1) and post-intervention (Week 14))
- Body Composition(Baseline (Week 1) and post-intervention (Week 14))
- Prostate Cancer Symptoms(Baseline (Week 1) and post-intervention (Week 14))
- Exercise Benefits and Barriers(Baseline (Week 1) and post-intervention (Week 14))
Investigators
Christina Dieli-Conwright, PhD
Principal Investigator
Dana-Farber Cancer Institute