Clinical trial · Interventional
Exercise Therapy and Radiation Therapy (EXERT) for Metastatic Prostate Cancer
NCT04556045CI-TRIAL-00110792completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm of Prostate | Malignant Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiation Therapy + Exercise Therapy
- description
- This group will receive exercise intervention in addition to their standard of care radiation treatment. At the baseline visit, they will meet with the certified exercise trainer (CET) and will be provided with a personalized exercise prescription and log to record what they do in between daily radiation treatment visits. The participant will also undergo an in-person exercise session prior to radiation therapy, which will take place either on the same day that the physical function tests are preformed or on a separate day. Participants will exercise between 1 and 7 times/week depending on the patient's tolerance to the exercise prescription. The CET will meet with the participant at every radiation treatment visit for an exercise counseling check-in. After five radiation treatments, the CET will follow-up with the participants via phone call once per week for 4 weeks during the follow-up period.
- interventionNames
- Behavioral: Exercise therapy
- type
- NO_INTERVENTION
- label
- Radiation Therapy
- description
- The observational group will continue with their usual standard of care of radiation therapy. The study team will provide patients with an educational pamphlet at the end of their baseline visit. They will also be provided with a self-directed exercise program framework. Additionally, the participant's medical record will be reviewed for serious adverse events during their time on study. Baseline and final measurements will be obtained.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 performance or be aggravated by exercise * Mental impairment leading to inability to complete study requirements * In-patient receiving radiation therapy for a radiation emergency (e.g. cord compression, Superior vena cava (SVC) syndrome, brain metastases) * High risk of fracture or spine instability (Mirels score ≥7, SINS ≥7) * Children (the protocol will only include men age 18 and older)
References
Publications (0)
Data not yet available
No reference posted for this study.