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

Protocol # :
Prostate Cancer
Prostatic Neoplasms
Not Applicable
Disease Sites
Principal Investigator
Kang, Dong-Woo Kang

Trial Description

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)

Eligibility Requirements

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

- 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.