This phase II trial compares the effect of exercise therapy and radiation therapy to radiation therapy alone (usual care) in patients with prostate cancer that has spread from where it first started to other places in the body (metastatic). Each year, 30,000 men in the United States (U.S.) are diagnosed with metastatic prostate cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Radiation therapy is critical in the care of these men because it lowers pain and slows tumor growth. Nonetheless, men with metastatic prostate cancer who are receiving radiation therapy typically live less than 2 years. Additionally, radiation therapy has side effects, which lower quality of life. Quality of life can predict how long patients can live, so if this metric can be improved, then their survival time may also improve. Exercise therapy has been shown to improve quality of life for cancer patients receiving chemotherapy. The combination of exercise therapy and radiation therapy for men with prostate cancer receiving radiation has never been studied. Giving exercise therapy and radiation therapy may improve quality of life and reduce the side effects of the radiation compared to radiation alone in patients with metastatic prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04556045.
Locations matching your search criteria
United States
Ohio
Cleveland
Case Comprehensive Cancer CenterStatus: Active
Contact: Nicholas G. Zaorsky
Phone: 216-844-2558
PRIMARY OBJECTIVE:
I. To quantify the potential effect of exercise therapy (ET) on patient-reported quality of life (QOL) in patients with metastatic prostate cancer (including distant sites or regional lymph nodes) using the Patient-Reported Outcomes Measurement Information System (PROMIS).
SECONDARY OBJECTIVES:
I. To measure the effect of ET on physical function in patients with prostate cancer undergoing radiation therapy (RT).
II. To measure progression-free survival (PFS) of patients with prostate cancer undergoing ET during RT.
III. To measure overall survival (OS) of patients with prostate cancer undergoing ET during RT.
CORRELATIVE OBJECTIVE:
I. Will measure levels of serum interleukin-1Ra (IL-1Ra) at the baseline and final study visit to determine the effect of RT + ET on this marker.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo radiation therapy per standard of care and wear Fitbit to monitor activity on study. Patients also undergo collection of blood samples on study.
ARM II: Patients undergo radiation therapy per standard of care and participate in exercise therapy consisting of exercise sessions and counseling with certified exercise trainer (CET) throughout their radiation therapy. Patients also wear Fitbit to monitor activity and undergo collection of blood samples on study.
After study completion, patients' medical records will be reviewed every 3-6 months to collect overall survival and cause of death up to 5 years.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorNicholas G. Zaorsky