Clinical trial · Interventional
Exercise for Tumor Suppressive Impact in Men With Prostate Cancer at High-Risk of Progression on Active Surveillance: The REMOVE Trial
NCT05918263CI-TRIAL-00118070recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-Intensity Interval Training Exercise Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A: HIIT Exercise Program
- 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 14 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.
- interventionNames
- Behavioral: High-Intensity Interval Training Exercise Program
- type
- EXPERIMENTAL
- label
- Group B: Waitlist Control
- 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 14 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 12-week HIIT exercise program.
- interventionNames
- Behavioral: High-Intensity Interval Training Exercise Program
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.