Clinical trial NCT05918263: Exercise for Tumor Suppressive Impact in Black Men With Prostate Cancer on Active Surveillance: The REMOVE Trial
Official title: Exercise for Tumor Suppressive Impact in Black Men With Prostate Cancer on Active Surveillance: The REMOVE Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Prostatic Neoplasms
Keywords: Prostate Cancer
Prostatic Neoplasms
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Prostate Cancer Foundation
First posted: 2023-06-26
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Primary outcomes:
measure: Prostate-Specific Antigen (PSA) Level
timeFrame: Baseline (Week 1) and post-intervention (Week 18)
Secondary outcomes:
measure: Prostate-Specific Antigen (PSA) Velocity
timeFrame: Baseline (Week 1) and post-intervention (Week 18)
measure: Prostate-Specific Antigen (PSA) Doubling Time
timeFrame: Baseline (Week 1) and post-intervention (Week 18)
measure: Proliferation of LNCaP Prostate Cancer Cell Line
timeFrame: Baseline (Week 1) and post-intervention (Week 18)
measure: Cardiorespiratory Fitness
timeFrame: Baseline (Week 1) and post-intervention (Week 18)
measure: Muscular Strength
timeFrame: Baseline (Week 1) and post-intervention (Week 18)
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline (Week 1) and post-intervention (Week 18)
measure: Health-Related Quality of Life
timeFrame: Baseline (Week 1) and post-intervention (Week 18)
measure: Prostate Cancer-Specific Anxiety
timeFrame: Baseline (Week 1) and post-intervention (Week 18)
measure: Fear of Cancer Progression Assessment
timeFrame: Baseline (Week 1) and post-intervention (Week 18)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christina Dieli-Conwright, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: