EXTEND: Safety and Efficacy of Exercise Training in Men Receiving Enzalutamide (ENZ) in Combination with Conventional Androgen Deprivation Therapy (ADT) for Hormone Naïve Prostate Cancer (HSPC)

Background: ADT is associated with physical side effects and a decline in cardiorespiratory fitness that can be mitigated with exercise (EX). Addition of a more potent androgen receptor inhibitor such as ENZ might worsen these effects. In this pilot study, we investigated whether an EX program could mitigate adverse changes from ADT + ENZ treatment.

Methods: Men starting ADT for M0 HSPC were treated with ADT + ENZ for 8 months and randomized to usual care (UC) or EX for 16 weeks. EX began 4 weeks prior to starting ADT + ENZ and consisted of 48 supervised exercise sessions delivered 3x/week between 55-80% of exercise capacity (VO₂peak) for aerobic training and 60-85% of one repetition maximum (1-RM) for resistance training. The primary endpoint was changed in VO₂peak from baseline to 16 weeks. Secondary endpoints included 6-minute walk distance (6MWD), upper and lower body strength (1-RM), body composition (DXA), and patient-reported outcomes (FACT-P, FACIT-Fatigue). The study was originally designed to recruit 56 subjects (N = 28/arm) but was halted early due to funding issues.

Results: 26 men (UC, N = 13; EX, N = 13) completed the protocol. Baseline age and BMI (mean ± standard deviation [SD]) was 65.0 ± 8.1 yr and 28.5 ± 4.6 kg/m2. Intention to treat analyses for mean 16-week change from baseline with a 95% confidence interval (CI) for each assessment by arm are presented in the table.

Conclusions: Supervised aerobic and resistance EX-resulted in less decline in VO₂peak, as well as improved function and strength in men treated with ADT + ENZ for M0 HSPC. EX was associated with less fat gain and muscle mass loss, less decline in QOL, and less increase in fatigue. Larger trials of EX in this setting are warranted.

Clinical trial identification: NCT02256111
Legal entity responsible for the study: Duke University Health System.
Funding: Pfizer (Medivation), Astellas.
Disclosure: All authors have declared no conflicts of interest.

Annals of Oncology, Volume 29, Issue suppl_8, 1 October 2018, mdy300.064, https://doi.org/10.1093/annonc/mdy300.064 Published: 23 October 2018

Authors: M.R. Harrison¹, P.G. Davis², M.G. Khouri³, R.T. Gupta⁴, A.J. Armstrong¹, M.A. McNamara⁵, T. Zhang¹, M. Anand⁶, K. Onyenwoke⁶, H. Hood⁶, S. Edwardson⁷, D. Craig⁷, Y. Wu⁸, P. Healy⁸, B. Coyne⁹, L. Jones¹⁰, D.J. George⁵Author Affiliation: ¹Division Of Medical Oncology, Duke Cancer Center, 27710 - Durham/US ²Department Of Kinesiology, UNCG, Greensboro/US ³Division Of Cardiology, Duke Cancer Center, Durham/US ⁴Department Of Radiology, Duke Cancer Center, Durham/US ⁵Division Of Medical Oncology, Duke Cancer Center, Durham/US ⁶Gu Oncology, Duke Cancer Center, Durham/US ⁷Health And Fitness Center, Duke University, Durham/US ⁸Biostatistics, Duke Cancer Center, Durham/US ⁹Cardiac Diagnostic Unit, Duke University Health System, Durham/US ¹⁰Exercise Oncology Research Program, Memorial Sloan Kettering Cancer Center, New York/US

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