Nicolas Hart, Editor in Chief at the Asia-Pacific Journal of Clinical Oncology and Professor at the University of Technology Sydney, shared a post on X:
“Feasibility and implementation outcomes of our global Phase III RCT examining vigorous exercise for survival in advanced prostate cancer. The GOOD news : 1-Year of vigorous hybrid-supervised exercise in men with advanced prostate cancer ( resistance and aerobic; 3 days per week ) had high adherence ( median: 84% ), and was well tolerated ( only 19 study-related adverse events among 145 randomised participants ) in people with a variety of complex multimorbidity profiles and concomitant medications: https://lnkd.in/gzJD2FY2 The CHALLENGES : Global study feasibility across the world was variable (13 of 21 activated sites actually recruited; with 4 sites recruiting ~80% of participants on-study).
The study closed early as a result ( randomising n=145 of its n=866 target ), acknowledging COVID-19 dramatically hampered efforts which cannot be understated. The LESSONS : We report our experience designing and implementing a global RCT across the world (7 countries) and highlight the key issues faced, and lessons or recommendations for others who seek to run similar trials in future. While our INTERVAL-GAP4 trial was on track to run a similar time horizon to the CHALLENGE trial; these trials are expensive and long-lasting (with evolving cost bases), thus our INTERVAL-GAP4 trial was not supported to continue following an interim analysis. What’s NEXT? : We have excellent data on n=145 men with metastatic prostate cancer involved in a 2-year exercise study.
Many helpful outcomes will arise from this comprehensive trial. A forthcoming paper will present the survival and physical fitness efficacy outcomes, for example. We hope the detailed information here (such as which types of trial sites worked best) helps in the design and realistic operation of future multinational large-scale trials by study teams and funders of this type of multidisciplinary work.
To support this trial among its suite of Global Action Plans nearly 15 years ago. How much the world has changed since.”
Title: Feasibility and Implementation of INTERVAL-GAP4: A Global Randomised Controlled Trial of Intense Hybrid-supervised/Self-managed Versus Self-directed Exercise for Metastatic Prostate Cancer
Authors: Stacey Kenfield, Nicolas Hart, Kerry Courneya, Rosemary Greenwood, June Chan, Jennette Sison, Li Zhang, Sarah Rudman, Leah Ung, Moritz Schumann, Erin Van Blarigan, Sam McKeown, Charles Ryan, James Catto, Daniel Galvão, Robert Newton, Fred Saad
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