Publication: 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)

Reference
Title	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)
Topic	Low-carbohydrate or ketogenic diet
Author	Freedland, S J, Allen, J, Jarman, A, Oyekunle, T, Armstrong, A J, Moul, J W, Sandler, H M, Posadas, E, Levin, D, Wiggins, E, Howard, L E, Wu, Y, Lin, P-H
Year	2020
Journal	Clinical Cancer Research
DOI	https://doi.org/10.1158/1078-0432.CCR-19-3873

Author's Abstract The abstract and the information and conclusions contained therein were written by the authors of the publication.

Introduction: Both weight loss and low carbohydrate diets (LCD) without weight loss prolong survival in prostate cancer (PC) models. Few human trials tested weight loss or LCD on PC. Methods: We conducted a multi-site randomized 6-month trial of LCD vs control on PSA doubling time (PSADT) in PC patients with biochemical recurrence (BCR) after local treatment. Eligibility included BMI ≥24 kg/m2 and PSADT 3-36 months. LCD was instructed to eat ≤20g/carbs/day; controls were 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. 27 LCD and 18 controls completed the study. At 6-month, while both arms consumed similar protein and fats, LCD reduced carbohydrates intake (-117 vs. 8g, p<0.001) and lost weight (-12.1 vs. -0.50Kg, p<0.001). LCD reduced HDL, triglycerides, and HbA1c with no difference in total cholesterol or glucose. Mean PSADT was similar between LCD (21 months) vs. control (15 months, p=0.316). In a post-hoc exploratory analysis accounting for pre-study PSADT, baseline PSA, primary treatment and hemoconcentration, PSADT was significantly longer in LCD vs. controls (28 vs 13 months, p=0.021). Adverse events were few, usually mild, and returned to baseline by 6-month. Conclusions: Among BCR patients, LCD induced weight loss and metabolic benefits with acceptable safety without affecting PSADT suggesting LCD does not adversely affect PC growth and is safe. Given exploratory findings of longer PSADT, larger studies testing LCD on disease progression are warranted.

This publication is referenced in the following studies:

1. Freedland et al. (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)