To determine if supervised high intensity aerobic and resistance training increases overall survival compared to self-directed exercise in patients with metastatic prostate cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
866
Cedars Sinai Medical Centre
Los Angeles, California, United States
UCSF
San Francisco, California, United States
Overall Survival
Overall survival will be measured from the time of randomization until death
Time frame: up to 5 years
Disease Progression
Time to disease progression will be measured from randomization until the first of the following: first CT or bone scan documenting disease progression, initiation of a new therapy for mPC (clinical progression), or first occurrence of a Symptomatic Skeletal Related Event (SSE).
Time frame: up to 5 years
Symptomatic Skeletal Related Events (SSE)
Time to first occurrence of SSE will be defined as the time from randomization to documentation of any of the following (whichever occurs first) + 1 day: * Use of external beam radiation therapy to relieve bone pain * Occurrence of new symptomatic pathological bone fractures that may be vertebral or non-vertebral. Asymptomatic compression fractures detected by radiology review only will not be considered a SSE. * Spinal cord compression * Change in antineoplastic therapy to treat bone pain * Surgical intervention to treat bone pain
Time frame: up to 5 years
Opiate Use
Opiate use will be assessed via BPI-SF, the medical record review at entry with a lead-in period (\<28 days). The questionnaires will be administered every three cycles until month 24, and in month 36.
Time frame: up to 5 years
Analgesic Use
Analgesic use will be assessed via BPI-SF, the World Health Organisation (WHO) analgesic scale, and medical record review at entry with a lead-in period (\<28 days). The WHO analgesic scale will be completed every three cycles (based on medical review) and questionnaires will be administered every three cycles until month 24, and in month 36.
Time frame: up to 5 years
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UC Denver
Denver, Colorado, United States
University of Minnesota
Minneapolis, Minnesota, United States
Oregon Health & Science University
Portland, Oregon, United States
Fred Hutchinson Cancer Centre
Seattle, Washington, United States
Australian Prostate Cncr Research Centre
Brisbane, Queensland, Australia
University of Queensland
Brisbane, Queensland, Australia
Victoria University / Sunshine Hospital
Melbourne, Victoria, Australia
Edith Cowan University
Perth, Western Australia, Australia
...and 8 more locations
Biomarker analysis
Inflammatory and cytokine systemic milieu
Time frame: up to 5 years
Biomarker analysis
Insulin/Glucose Metabolism
Time frame: up to 5 years
Biomarker analysis
Androgen biosynthesis
Time frame: up to 5 years
Quality of Life
Physical and emotional quality of life measured by the questionnaires- Functional Assessment of Cancer Therapy- Prostate (FACT-P), Functional assessment of Chronic Illness Therapy (FACIT-Fatigue), and EuroQOL Five Dimension Questionnaire (EQ5D) will be assessed every 3 cycles.
Time frame: up to 5 years
Physical Function
Physical function will be assessed using strength assessments (1RM), a cardiopulmonary exercise test (CPET) and a functional performance test (400m walk)
Time frame: up to 5 years
Pain
Pain will be assessed via questionnaire Brief Pain Inventory- short form (BPI-SF) and medical record review at entry with a lead-in period (\<28 days) and repeated measures will occur every three cycles
Time frame: up to 5 years