Exercise Therapy and Radiation Therapy (EXERT) for Metastatic Prostate Cancer (NCT04556045) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Exercise Therapy and Radiation Therapy (EXERT) for Metastatic Prostate Cancer
United States80 participantsStarted 2023-12-11
Plain-language summary
This study is being done to determine if patients receiving personalized exercise therapy (versus those who do not receive personalized exercise therapy) have improved quality of life and physical functioning after completing their radiation therapy. Second, the study is being done to find if the quality of life changes during therapy correlate with measurements of inflammation in the blood. Third, the study is being done to see if adding exercise therapy to radiation therapy will improve survival.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects must have lymph node positive or metastatic disease consistent with prostate cancer
* Males ≥18 years of age receiving RT
* Patient receiving 5 fractions or stereotactic body radiation therapy (SBRT)
* Patient may have received prior hormone therapy. Prior or current use of chemotherapy agents is allowed, but not necessary.
* Fluent in written and spoken English
* Must be able to provide and understand informed consent
* Must have an ECOG Performance Status (PS) of ≤ 3
* Primary attending radiation oncologist approval
Exclusion Criteria:
* Performing \> 90 minutes/week of exercise therapy prior at time of enrollment
* Evidence in the medical record of an absolute contraindication for exercise
* Cardiac exclusion criteria:
* Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
* History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty or stenting within the past 6 months prior to the start of radiation therapy
* Uncontrolled arrhythmias; patients with rate-controlled atrial fibrillation for \>1 month prior to start of radiation therapy may be eligible
* syncope
* acute myocarditis, pericarditis, or endocarditis
* acute pulmonary embolus or pulmonary infarction
* thrombosis of lower extremities
* suspected dissecting aneurysm
* pulmonary edema
* respiratory failure
* acute non-cardiopulmonary disorder that may affect exercise…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quality of life using the Patient-Reported Outcomes Measurement Information System (PROMIS Scale v1.2-Global Health)