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.
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 20 g/carbs/day; controls were instructed to avoid dietary changes. Primary outcome was PSADT. Secondary outcomes included weight, lipids, glucose metabolism, and diet.
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.
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.
Clinical cancer research : an official journal of the American Association for Cancer Research. 2020 Feb 27 [Epub ahead of print]
Stephen J Freedland, Jenifer Allen, Aubrey Jarman, Taofik Oyekunle, Andrew J Armstrong, Judd W Moul, Howard Sandler, Edwin M Posadas, Dana Levin, Emily Wiggins, Lauren E Howard, Yuan Wu, Pao-Hwa Lin
Surgery, Cedars-Sinai Medical Center ., Translational Population Health Research, Duke Clinical and Translational Science Institute., Surgery, Cedars-Sinai Medical Center., Duke Cancer Institute, Duke University School of Medicine., Divisions of Medical Oncology and Urology, Departments of Medicine and Surgery, Duke Cancer Institute., Surgery, Duke Medical Center., Radiation Oncology, Cedars-Sinai Medical Center., Urologic Oncology Program & Uro-Oncology Research Laboratories, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center., Urology, Cedars-Sinai Medical Center., Surgery, Durham VA Medical Center., Department of Biostatistics and Bioinformatics, Duke University School of Medicine., Biostatistics and Bioinformatics, Duke Medical Center., Medicine, Duke Medical Center.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/32108029
Clinical Trial Information: NCT01763944