Exercise program to slow prostate cancer progression in Black men
Exercise for Tumor Suppressive Impact in Black Men With Prostate Cancer on Active Surveillance: The REMOVE Trial
NA · Dana-Farber Cancer Institute · NCT05918263
This study is testing whether a 16-week exercise program can help Black men with early-stage prostate cancer slow down the progression of their disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Dana-Farber Cancer Institute (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT05918263 on ClinicalTrials.gov |
What this trial studies
This research focuses on a 16-week, home-based, virtually supervised exercise program aimed at Black men with early-stage prostate cancer who are on active surveillance. Participants will be randomly assigned to either an aerobic high-intensity interval training (HIIT) group or a usual care group. The study aims to assess whether this exercise intervention can effectively slow cancer progression, addressing a significant gap in research involving Black men, who are at a higher risk for progression. The study will include eligibility screenings, treatment visits, and follow-up assessments over approximately 18 weeks.
Who should consider this trial
Good fit: Ideal candidates are Black men aged 18 and older with early-stage localized prostate cancer who are undergoing active surveillance.
Not a fit: Patients with uncontrolled medical conditions that could worsen with exercise or those planning invasive treatment within the next 16 weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could provide a non-invasive method to slow the progression of prostate cancer in Black men.
How similar studies have performed: While there is preliminary evidence suggesting exercise may suppress cancer progression, this specific approach targeting Black men with prostate cancer is novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Boston, Massachusetts and 2 other locations
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Christina Dieli-Conwright, PhD, MPH — Dana-Farber Cancer Institute
- Study coordinator: Christina Dieli-Conwright, PhD, MPH
- Email: ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU
- Phone: 617-582-8321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Prostatic Neoplasms