Exercise for Tumor Suppressive Impact in Black Men With Prostate Cancer on Active Surveillance: The REMOVE Trial
1 other identifier
interventional
68
1 country
3
Brief Summary
The purpose of this study is to determine whether a 16-week, home-based, virtually supervised exercise program will slow cancer progression of prostate cancer among Black men with prostate cancer undergoing active surveillance. The name of the study intervention involved in this study is: Aerobic high-intensity interval training (HIIT) (training exercise intervention)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Jan 2024
Typical duration for not_applicable prostate-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2023
CompletedFirst Posted
Study publicly available on registry
June 26, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
May 5, 2026
May 1, 2026
3.2 years
June 14, 2023
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prostate-Specific Antigen (PSA) Level
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.
Baseline (Week 1) and post-intervention (Week 18)
Secondary Outcomes (9)
Prostate-Specific Antigen (PSA) Velocity
Baseline (Week 1) and post-intervention (Week 18)
Prostate-Specific Antigen (PSA) Doubling Time
Baseline (Week 1) and post-intervention (Week 18)
Proliferation of LNCaP Prostate Cancer Cell Line
Baseline (Week 1) and post-intervention (Week 18)
Cardiorespiratory Fitness
Baseline (Week 1) and post-intervention (Week 18)
Muscular Strength
Baseline (Week 1) and post-intervention (Week 18)
- +4 more secondary outcomes
Study Arms (2)
Group A: 16-Week HIIT Exercise Program
EXPERIMENTALParticipants 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, 9, and 19 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.
Group B: 16-Week Usual Care
EXPERIMENTALParticipants 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 18 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 16-week HIIT exercise program.
Interventions
Home-based, virtually supervised, aerobic exercise program of 48 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.
Eligibility Criteria
You may qualify if:
- Age ≥18 years; due to the rarity of the disease in those \<18 years, this age bracket will not be included
- Self-identify as Black
- Diagnosed with early-stage (e.g., very-low to favorable-intermediate grade), localized prostate cancer
- Initiating or having been undergoing active surveillance
- No plans for invasive treatment for their prostate cancer in the following 16 weeks from the time of enrollment
- Medical clearance to perform exercise intervention and testing by their treating urologist
- No uncontrolled medical conditions that could be exacerbated with exercise
- Ability to communicate and complete written forms in English
- Participate in less than or equal to 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month
- Ability to understand and the willingness to sign informed consent prior to any study-related procedures
- Willing to travel to Dana-Farber Cancer Institute for necessary data collection
You may not qualify if:
- Receiving any invasive curative-intent treatment for prostate cancer, including surgery, chemotherapy, radiation therapy, and hormonal therapy. This study is to exclusively target patients on active surveillance who are not receiving curative cancer treatment and to examine the effects of the intervention on biochemical progression of existing prostate tumor.
- Patients with metastasis and/or other active malignancies (except basal cell carcinoma) and/or receiving treatment for those malignancies. This study is to exclusively target patients with early-stage prostate cancer on active surveillance to investigate the effects of the intervention on biochemical progression of prostate tumor, as such other active malignancies or any relevant treatment may contaminate the study results.
- Participate in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention effects.
- Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because part of this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded.
- Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Prostate Cancer Foundationcollaborator
Study Sites (3)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Dieli-Conwright, PhD, MPH
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Principle investigators blinded to block size
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 14, 2023
First Posted
June 26, 2023
Study Start
January 1, 2024
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.