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A Randomized Controlled Trial of a 6-Month Low-Carbohydrate Intervention on Disease Progression in Men with Recurrent Prostate Cancer: Carbohydrate and Prostate Study 2 (CAPS2).

Publication ,  Journal Article
Freedland, SJ; Allen, J; Jarman, A; Oyekunle, T; Armstrong, AJ; Moul, JW; Sandler, HM; Posadas, E; Levin, D; Wiggins, E; Howard, LE; Wu, Y; Lin, P-H
Published in: Clin Cancer Res
June 15, 2020

PURPOSE: Both weight loss and low-carbohydrate diets (LCD) without weight loss prolong survival in prostate cancer models. Few human trials have tested weight loss or LCD on prostate cancer. EXPERIMENTAL DESIGN: We conducted a multi-site randomized 6-month trial of LCD versus control on PSA doubling time (PSADT) in patients with prostate cancer with biochemical recurrence (BCR) after local treatment. Eligibility included body mass index (BMI) ≥ 24 kg/m2 and PSADT 3 to 36 months. The LCD arm was instructed to eat [Formula: see text]20 g/carbs/day; the control arm instructed to avoid dietary changes. Primary outcome was PSADT. Secondary outcomes included weight, lipids, glucose metabolism, and diet. RESULTS: Of 60 planned patients, the study stopped early after an interim analysis showed futility. Twenty-seven LCD and 18 control patients completed the study. At 6 months, although both arms consumed similar protein and fats, the LCD arm reduced carbohydrates intake (-117 vs. 8 g, P < 0.001) and lost weight (-12.1 vs. -0.50 kg, P < 0.001). The LCD arm reduced HDL, triglycerides, and HbA1c with no difference in total cholesterol or glucose. Mean PSADT was similar between LCD (21 months) and control (15 months, P = 0.316) arms. In a post hoc exploratory analysis accounting for prestudy PSADT, baseline PSA, primary treatment, and hemoconcentration, PSADT was significantly longer in LCD versus control (28 vs. 13 months, P = 0.021) arms. Adverse events were few, usually mild, and returned to baseline by 6 months. CONCLUSIONS: Among BCR patients, LCD induced weight loss and metabolic benefits with acceptable safety without affecting PSADT, suggesting LCD does not adversely affect prostate cancer growth and is safe. Given exploratory findings of longer PSADT, larger studies testing LCD on disease progression are warranted.

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Published In

Clin Cancer Res

DOI

EISSN

1557-3265

Publication Date

June 15, 2020

Volume

26

Issue

12

Start / End Page

3035 / 3043

Location

United States

Related Subject Headings

  • Weight Loss
  • Survival Rate
  • Prostatic Neoplasms
  • Prostatectomy
  • Prognosis
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Male
  • Humans
  • Follow-Up Studies
 

Citation

APA
Chicago
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MLA
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Freedland, S. J., Allen, J., Jarman, A., Oyekunle, T., Armstrong, A. J., Moul, J. W., … Lin, P.-H. (2020). A Randomized Controlled Trial of a 6-Month Low-Carbohydrate Intervention on Disease Progression in Men with Recurrent Prostate Cancer: Carbohydrate and Prostate Study 2 (CAPS2). Clin Cancer Res, 26(12), 3035–3043. https://doi.org/10.1158/1078-0432.CCR-19-3873
Freedland, Stephen J., Jenifer Allen, Aubrey Jarman, Taofik Oyekunle, Andrew J. Armstrong, Judd W. Moul, Howard M. Sandler, et al. “A Randomized Controlled Trial of a 6-Month Low-Carbohydrate Intervention on Disease Progression in Men with Recurrent Prostate Cancer: Carbohydrate and Prostate Study 2 (CAPS2).Clin Cancer Res 26, no. 12 (June 15, 2020): 3035–43. https://doi.org/10.1158/1078-0432.CCR-19-3873.
Freedland SJ, Allen J, Jarman A, Oyekunle T, Armstrong AJ, Moul JW, et al. A Randomized Controlled Trial of a 6-Month Low-Carbohydrate Intervention on Disease Progression in Men with Recurrent Prostate Cancer: Carbohydrate and Prostate Study 2 (CAPS2). Clin Cancer Res. 2020 Jun 15;26(12):3035–43.
Freedland, Stephen J., et al. “A Randomized Controlled Trial of a 6-Month Low-Carbohydrate Intervention on Disease Progression in Men with Recurrent Prostate Cancer: Carbohydrate and Prostate Study 2 (CAPS2).Clin Cancer Res, vol. 26, no. 12, June 2020, pp. 3035–43. Pubmed, doi:10.1158/1078-0432.CCR-19-3873.
Freedland SJ, Allen J, Jarman A, Oyekunle T, Armstrong AJ, Moul JW, Sandler HM, Posadas E, Levin D, Wiggins E, Howard LE, Wu Y, Lin P-H. A Randomized Controlled Trial of a 6-Month Low-Carbohydrate Intervention on Disease Progression in Men with Recurrent Prostate Cancer: Carbohydrate and Prostate Study 2 (CAPS2). Clin Cancer Res. 2020 Jun 15;26(12):3035–3043.

Published In

Clin Cancer Res

DOI

EISSN

1557-3265

Publication Date

June 15, 2020

Volume

26

Issue

12

Start / End Page

3035 / 3043

Location

United States

Related Subject Headings

  • Weight Loss
  • Survival Rate
  • Prostatic Neoplasms
  • Prostatectomy
  • Prognosis
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Male
  • Humans
  • Follow-Up Studies