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Exercise for Tumor Suppressive Impact in Men With Prostate Cancer at High-Risk of Progression on Active Surveillance: The REMOVE Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The research study procedures include screening for eligibility, study treatment visits, survey questionnaires, blood tests, and follow-up visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether 12 weeks of exercise at home, with online supervision, can slow prostate cancer growth or spread. It is for men at higher risk of their cancer getting worse who are being closely watched rather than treated right away (active surveillance). The exercise uses short bursts of hard aerobic activity, called high-intensity interval training (HIIT).

The purpose of this study is to determine whether a 12-week, home-based, virtually supervised exercise program will slow cancer progression of prostate cancer among men with prostate cancer at high-risk of progression undergoing active surveillance. The name of the study intervention involved in this study is: Aerobic high-intensity interval training (HIIT) (training exercise intervention)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have prostate cancer confirmed by a tissue sample that has not spread beyond the prostate.
  • Are starting or already on active surveillance.
  • Have at least one higher-risk factor: a tumor rated “favorable-intermediate risk” at diagnosis, obesity (body mass index of 30 or higher), or identify as Black or African American.
  • Have no plans for invasive prostate cancer treatment in the 12 weeks after joining.
  • Can understand the study and are willing to give informed consent, meaning agreement to take part.

Who can't join

  • Have had prostate cancer treatment meant to cure it, including surgery, chemotherapy, radiation, or hormone therapy.
  • Have cancer that has spread, another active cancer, or are receiving treatment for another cancer. Basal cell skin cancer is allowed.
  • Do any high-intensity exercise when being considered for the study.
  • Have a long-term health problem that is unstable or not controlled with medicine and makes exercise unsafe. Examples include unstable heart disease, uncontrolled diabetes, or cancer in bones that may soon break.
  • The study team finds a high risk of not following study steps, based on 3 or more missed cancer appointments in 6 months and 3 or more unanswered contacts during recruitment.
  • Do not speak English and cannot complete the study surveys.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age ≥18 years. * Histologically diagnosed with localized prostate cancer. * Initiating or undergoing active surveillance. * Having a higher risk of progression, defined as meeting one or more of the following: (1) favorable- intermediate risk prostate tumor at diagnosis, (2) obesity (body mass index ≥ 30), and/or (3) self- identified as Black or African American. * No plans for invasive treatment for their prostate cancer in the 12 weeks following the time of enrollment. * Ability to understand and willingness to provide informed consent. Exclusion Criteria: * Received any invasive curative-intent treatment for prostate cancer, including surgery, chemotherapy, radiation therapy, and hormonal therapy. * Patients with metastasis and/or other active malignancies (except basal cell carcinoma) and/or receiving treatment for those malignancies. * Participating in any (\>0 min/week) high-intensity exercise at the time of recruitment. * Having chronic medical conditions that are clinically unstable or uncontrolled with medications, deemed high-risk for exercise. These include but are not limited to unstable cardiac diseases, uncontrolled diabetes, and bone metastases with imminent risk of fracture. * Having a high risk for noncompliance with study procedures. This will be determined by the study team based on the history of missed oncology appointments (i.e., ≥3 no-shows in 6 months) and poor responsiveness during recruitment (i.e., ≥3 unreturned contacts). * Patients who are non-English speaking and unable to complete the participant surveys.

Study sites (4)

MA

WA