Transl Behav Med. 2026 Jan 7;16(1):ibag069. doi: 10.1093/tbm/ibag069.
ABSTRACT
BACKGROUND: Prostate cancer (PCa) is the most common cancer in US men. Nearly half of those diagnosed with PCa present with low-risk disease based on clinical guidelines, for which active surveillance (AS) is increasingly recommended by clinicians to avoid invasive treatment. Obesity is a well-recognized risk factor for poor PCa prognosis. Yet weight loss interventions for PCa patients on AS are limited.
PURPOSE: Using the NIH Stage Model for Behavioral Intervention Development as a guide, our Stage 1 study translated and assessed the feasibility, estimated preliminary efficacy signals, and conducted exploratory analyses of two evidence-based behavioral weight loss interventions for PCa patients on AS.
METHODS: We worked with patients to translate evidence-based continuous energy restriction (CER) and 5:2 (two 600 kcal fast days, eat normally 5 days) intermittent fasting (IF) interventions for PCa patients on AS. Feasibility, estimated preliminary efficacy signals, and exploratory analyses on outcomes from baseline to 3 and 6 months was assessed using a parallel arm randomized controlled trial.
RESULTS: The study met the pre-established benchmarks for feasibility. Twenty patients were randomized (10 CER, 10 IF). All were retained over 6-month follow-up. Participants were predominantly White (95%), with an average age of 65.9 (SD 8.45) years. Each arm produced clinically meaningful weight loss from baseline to 6 months (CER -5.79% [95% confidence interval, CI: -3.48, -8.09; P < .01); IF -7.50% (95% CI: -5.19, -9.80; P < .01). Within IF only, there were favorable exploratory changes in biomarkers related to lipid and glucose metabolism, inflammation and immune function, and signaling pathways critical for PCa progression.
CONCLUSIONS: Our study provides evidence for our interventions’ feasibility and preliminary efficacy signals for clinically meaningful weight loss in PCa patients on AS. Future studies examining weight loss’ impact on PCa progression and related biomarkers are needed.
CLINICAL TRIAL INFORMATION: The Clinical Trials Registration NCT05764330.
PMID:42816069 | DOI:10.1093/tbm/ibag069
