Intense exercise for survival among men with metastatic castrate-resistant prostate cancer (INTERVAL – MCRPC): A Movember funded multicenter, randomized, controlled phase III study.
Year: 2016
Type: conference-abstract
Abstract: TPS5092 Background: Provocative evidence supports the beneficial role of physical activity on prostate cancer survivorship. Evaluating exercise as a low-toxicity adjuvant intervention that can be combined with standard therapy to improve outcomes in men with prostate cancer could reduce the clinical and public health burden of the disease. Exercise may affect prostate cancer survival via inflammation, hormonal, and energy metabolism pathways. Methods: Our goal is to compare overall survival (OS) among men with MCRPC randomly assigned to psychosocial support +/- high intensity aerobic and resistance training for 24 months. Secondary outcomes include: time to disease progression, occurrence of a skeletal-related event, or progression of pain; and degree of pain, opiate use, and physical and emotional quality of life. We will assess if inflammation, dysregulation of insulin and energy metabolism, and androgen biomarkers are associated with OS, and if they mediate the primary association between exercise and OS. The study will establish a biobank for future biomarker discovery or validation. This multi-site global trial will include MCRPC patients who are treatment naive or on abiraterone and/or enzalutamide without evidence of progression at enrolment. Patients will be randomized (1:1) to psychosocial support +/- high intensity aerobic and resistance training. The first 12 months of training will include a structured period of tapered supervised exercise with increasing self-managed exercise and behavioral support with text messages, to support self-management for an additional 12 months. Exercise prescriptions will be tailored to participant’s fitness and cancer/treatment morbidities. Assuming a median OS of 33.5 months in the controls, the sample size to detect a hazard ratio of 0.78 with 80% power at significance level of 0.05 is 824; assuming missing data on OS for 5%, we aim to enroll 866 men. Conclusion: This is the first prospective randomized trial to examine exercise and survival in men with prostate cancer; and is designed to elucidate the mechanisms by which exercise delays cancer progression.
Source: Journal of Clinical Oncology
Authors: Fred Saad, Stacey A. Kenfield, June M. Chan, Nicolas H. Hart, Kerry S. Courneya, James Catto, Stephen P. Finn, Rosemary Greenwood, Daniel C Hughes, Lorelei A. Mucci, Stephen R Plymate, Michael N. Pollak, Stephan F.E. Praet, Aaron P. Russell, Emer M. Guinan, Erin Van Blarigan, Orla Casey, Mark Buzza, Charles J. Ryan, Robert Usher Newton
Institutions: Université de Montréal, University of California, San Francisco, Edith Cowan University, University of Alberta, University of Sheffield, Trinity College Dublin, University Hospitals Bristol NHS Foundation Trust, The University of Texas at San Antonio Health Science Center, Harvard University, University of Washington, Jewish General Hospital, Deakin University, Movember Foundation, UCSF Helen Diller Family Comprehensive Cancer Center
Language: English
Topic: Cancer survivorship and care
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2749999113