Exercise Therapy and Radiation Therapy (EXERT) for Metastatic Prostate Cancer

NCT04556045 | Active Not Recruiting

• 1 other identifier: CASE8821
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Neoplasm of Prostate

Keywords

Exercise; Radiation; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Quality of life using the Patient-Reported Outcomes Measurement Information System (PROMIS Scale v1.2-Global Health)

  Patient Reported Outcome Measurement Information System (PROMIS) Global Health v1. 2 short form is a 10-item instrument representing multiple domains. Scores are assigned for both Global Physical Health component and Global Mental Health component. The response scores range from 1-5, where 1 = always and 5 = Never. A higher score from responses indicate better health.

  At 12 week follow up

Secondary Outcomes (10)

• Progression free survival

  Within 5 years

• Overall survival

  Within 5 years

• Physical Function: Short Physical Performance Battery

  At 1 month follow up

• Aerobic Capacity: Six Minute Walk Test

  At 1 month follow up

• Strength: Hand Grip Strength measured by the grip strength dynamometer test

  At 1 month follow up

Other Outcomes (3)

• Work Productivity and Activity Impairment Questionnaire

  At 1 month follow up

• Barriers to Exercise RM 5-FM

  At 1 month follow up

• Exploratory pro-inflammatory (IL-1B, IL-6, TNF-α, IL-8, IL-15, CRP) and anti-inflammatory (IL-10) markers

  At 1 month follow up

Study Arms (2)

Radiation Therapy + Exercise Therapy

EXPERIMENTAL

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.

Behavioral: Exercise therapy

Radiation Therapy

NO INTERVENTION

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.

Interventions

Exercise therapy BEHAVIORAL

The exercise therapy intervention will last 4 weeks. Each participant assigned to this intervention will receive a personalized ET regimen, including in-person, supervised exercise sessions; other activities to be followed at home. Participants will exercise between one and seven times per week depending on their tolerance to the treatment and exercise program.

Radiation Therapy + Exercise Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Performing \> 90 minutes/week of exercise therapy prior at time of enrollment
• Evidence in the medical record of an absolute contraindication for exercise
• 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)

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Angela Jia, MD, PhD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: September 21, 2020
• Study Start: December 11, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)