Clinical pathological changes in prostate cancer patients after hormonal therapy: A single-center pilot study

Prostate cancer (PCa) remains a leading malignancy with variable prognosis, and while PSA is widely used for disease monitoring, it frequently lacks sufficient specificity. This study investigated plasma coagulation parameters, inflammatory cytokines, and molecular markers as complementary biomarkers in PCa patients undergoing hormonal therapy.

In a prospective single-center pilot study, patients with newly diagnosed PCa were evaluated alongside patients with benign prostatic hyperplasia (BPH) and healthy men as controls. Coagulation parameters (PT, INR, APTT, fibrinogen, D-dimer), inflammatory cytokines (IFN-γ, IL-1β, TGF-β), and gene expression of p53 and NF-κB were measured before and after six months of hormonal therapy. Statistical analyses included non-parametric tests, ROC curve analysis, Firth penalized logistic regression adjusted for age, tumor grade, and PSA, and internal validation via 5-fold cross-validation and 1000-iteration bootstrapping.

PCa patients exhibited a hypercoagulable state, with elevated IL-1β, p53, and NF-κB, alongside reduced IFN-γ and TGF-β, compared with BPH and healthy controls. Hormonal therapy partially reversed these alterations toward values observed in the BPH and healthy control groups. ROC analysis demonstrated high discriminatory potential for IL-1β and NF-κB (AUC = 1.000) in the full dataset; however, this likely reflects near-perfect group separation in a small cohort (n = 32 PCa). Internal validation via 5-fold cross-validation and 1000-iteration bootstrapping yielded a corrected mean AUC of 0.725 (95% CI: 0.58-0.87), which is the primary performance estimate reported.

Coagulation disturbances, cytokine imbalance, and alterations in molecular markers are closely associated with PCa biology and short-term therapeutic response. These findings are hypothesis-generating, and long-term clinical endpoints, including biochemical recurrence and survival, require evaluation in adequately powered, multicenter longitudinal studies before these biomarkers can be considered for clinical integration.