RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

Official Title

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

Quick Facts

Study Start:2024-01-01

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05918263

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Dong-Woo Kang, PhD

CONTACT

617-582-7494

Dong-Woo_Kang@dfci.harvard.edu

Principal Investigator

Dong-Woo Kang, PhD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Dong-Woo Kang, PhD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-01

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2024-01-01

Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

Prostate Cancer
Prostatic Neoplasms

Additional Relevant MeSH Terms

Prostate Cancer
Prostatic Neoplasms