Exercise for Tumor Suppressive Impact in Black Men With Prostate Cancer on Active Surveillance: The REMOVE Trial

Launched by DANA-FARBER CANCER INSTITUTE · Jun 23, 2023

Keywords

ClinConnect Summary

The REMOVE Trial is a research study that aims to find out if a 16-week exercise program can help slow down the progression of prostate cancer in Black men who are being monitored for early-stage prostate cancer. This program involves high-intensity interval training (HIIT), which is a form of exercise that alternates between short bursts of intense activity and rest. The researchers want to see if regular exercise can make a difference for men who are currently not receiving treatment for their cancer.

To participate in this study, you need to be at least 18 years old, identify as Black, and have early-stage localized prostate cancer that is being actively monitored, meaning you are not currently undergoing any invasive treatments like surgery or chemotherapy. You should also have your doctor’s approval to exercise and should not be exercising more than 60 minutes per week right now. If you join the study, you will do the exercise at home with supervision through virtual sessions, and you’ll need to visit Dana-Farber Cancer Institute for some check-ins. This study is important because it could help find new ways to support men with prostate cancer through exercise.

Gender

MALE

Eligibility 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.