Loading clinical trials...

ACTIVE_NOT_RECRUITINGNA

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

NCT05918263•Dana-Farber Cancer Institute

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)

Detailed Description

This research study is a randomized controlled study for a home-based, virtually supervised, aerobic exercise intervention for Black men with prostate cancer undergoing active surveillance. There is evidence that exercise may suppress cancer progression, but the evidence is preliminary and Black men with prostate cancer has been highly underrepresented in exercise clinical research despite their higher risk of cancer progression compared to White counterparts. Participants will be randomized into one of two treatment groups: Group A: Aerobic high-intensity interval training (HIIT) versus Group B: Usual Care. Randomization means a participant is placed into a study group by chance. The research study procedures include screening for eligibility, study treatment visits, survey questionnaires, blood tests, and follow-up visits. Participation in this research study is expected to last about 18 weeks. It is expected that about 68 people will take part in this research study. The Prostate Cancer Foundation is providing funding for this research study.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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
+1 more criteria

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.

Locations (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

January 1, 2024

Primary Completion Date

March 31, 2026

Completion Date

March 31, 2027

Last Updated

March 12, 2026

Enrollment

ESTIMATED participants

Conditions

Prostate CancerProstatic Neoplasms

Interventions

High-Intensity Interval Training Exercise Program

BEHAVIORAL

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

View study

RECRUITINGPHASE2

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC