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

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Prostatic Neoplasms; Prostate Cancer

Treatments: Behavioral: High-Intensity Interval Training Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05918263

23-119

Details and patient eligibility

About

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)

Full 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.

Enrollment: 68 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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
• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Group A: 16-Week HIIT Exercise Program

Experimental group

Description:

Participants will be allocated in a 1:1 ratio, using a permuted blocked design with varying block size. Study procedures will be conducted as follows: * Testing visits at Week 1, 9, and 19 for physical exams, physical fitness and function assessments, survey questionnaires, and cardiopulmonary fitness assessment. * Virtual, aerobic training sessions three times weekly with trained oncology exercise specialist.

Treatment:

Behavioral: High-Intensity Interval Training Exercise Program

Group B: 16-Week Usual Care

Experimental group

Description:

Participants will be allocated in a 1:1 ratio, using a permuted blocked design with varying block size. Study procedures will be conducted as follows: * Testing visits at Week 1 and 18 for physical exams, physical fitness and function assessments, and survey questionnaires. * Upon completion of post-intervention assessments, participants will have the option to take part in the 16-week HIIT exercise program.

Treatment:

Behavioral: High-Intensity Interval Training Exercise Program