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A randomized controlled trial comparing changes in fitness with or without supervised exercise in patients initiated on enzalutamide and androgen deprivation therapy for non-metastatic castration-sensitive prostate cancer (EXTEND).

Publication ,  Journal Article
Harrison, MR; Davis, PG; Khouri, MG; Bartlett, DB; Gupta, RT; Armstrong, AJ; McNamara, MA; Zhang, T; Anand, M; Onyenwoke, K; Edwardson, S ...
Published in: Prostate Cancer Prostatic Dis
March 2022

BACKGROUND: Androgen deprivation therapy (ADT) and androgen receptor signaling inhibitors (ARSI) are associated with deleterious physical effects, which exercise may mitigate; however, exercise has never been studied in patients initiating treatment with ADT and an ARSI. Our objective was to determine whether supervised exercise prior to and during initial therapy could mitigate adverse effects of ADT plus enzalutamide. METHODS: We conducted a single center trial in patients with recurrent prostate cancer treated with ADT and enzalutamide. We randomized 26 patients to 16 weeks of supervised exercise (aerobic and resistance), starting 4 weeks before initiation of ADT and enzalutamide, or usual care. The primary endpoint was change in peak oxygen uptake (VO2peak) as a measure of cardiorespiratory fitness (CRF). Secondary endpoints were functional capacity, maximal strength, body composition, patient-reported outcomes, safety, and feasibility. Analysis of covariance was used to compare outcomes for groups at Week 17 adjusted for baseline values. RESULTS: The usual care group (N = 13) showed declines from baseline to week 17 in both absolute CRF (-0.31 L/min, -10.9%; p < 0.01) and relative CRF (-3.2 mL/kg/min, -8.9%; p = 0.04); worse fatigue (p = 0.01); and worse quality of life (p = 0.01). At week 17, the exercise group (N = 13) demonstrated improved absolute CRF (between-group change +0.20 L/min, p = 0.05), leg strength (+48.6 kg, p < 0.01) and functional capacity (+21.0 m, p = 0.01) at week 17. CONCLUSIONS: This is the first randomized controlled trial demonstrating a clinically significant decline in CRF in patients initiating ADT and enzalutamide. We show the effectiveness of short-term supervised exercise to mitigate declines in absolute CRF, and improve maximal leg strength and functional capacity. GOV IDENTIFIER: NCT02256111.

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Published In

Prostate Cancer Prostatic Dis

DOI

EISSN

1476-5608

Publication Date

March 2022

Volume

25

Issue

1

Start / End Page

58 / 64

Location

England

Related Subject Headings

  • Urology & Nephrology
  • Quality of Life
  • Prostatic Neoplasms
  • Phenylthiohydantoin
  • Orchiectomy
  • Nitriles
  • Neoplasm Recurrence, Local
  • Male
  • Humans
  • Exercise Therapy
 

Citation

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Harrison, M. R., Davis, P. G., Khouri, M. G., Bartlett, D. B., Gupta, R. T., Armstrong, A. J., … George, D. J. (2022). A randomized controlled trial comparing changes in fitness with or without supervised exercise in patients initiated on enzalutamide and androgen deprivation therapy for non-metastatic castration-sensitive prostate cancer (EXTEND). Prostate Cancer Prostatic Dis, 25(1), 58–64. https://doi.org/10.1038/s41391-022-00519-4
Harrison, Michael R., Paul G. Davis, Michel G. Khouri, David B. Bartlett, Rajan T. Gupta, Andrew J. Armstrong, Megan A. McNamara, et al. “A randomized controlled trial comparing changes in fitness with or without supervised exercise in patients initiated on enzalutamide and androgen deprivation therapy for non-metastatic castration-sensitive prostate cancer (EXTEND).Prostate Cancer Prostatic Dis 25, no. 1 (March 2022): 58–64. https://doi.org/10.1038/s41391-022-00519-4.
Harrison MR, Davis PG, Khouri MG, Bartlett DB, Gupta RT, Armstrong AJ, McNamara MA, Zhang T, Anand M, Onyenwoke K, Edwardson S, Craig D, Michalski M, Wu Y, Oyekunle T, Coyne B, Coburn A, Jones LW, George DJ. A randomized controlled trial comparing changes in fitness with or without supervised exercise in patients initiated on enzalutamide and androgen deprivation therapy for non-metastatic castration-sensitive prostate cancer (EXTEND). Prostate Cancer Prostatic Dis. 2022 Mar;25(1):58–64.

Published In

Prostate Cancer Prostatic Dis

DOI

EISSN

1476-5608

Publication Date

March 2022

Volume

25

Issue

1

Start / End Page

58 / 64

Location

England

Related Subject Headings

  • Urology & Nephrology
  • Quality of Life
  • Prostatic Neoplasms
  • Phenylthiohydantoin
  • Orchiectomy
  • Nitriles
  • Neoplasm Recurrence, Local
  • Male
  • Humans
  • Exercise Therapy