Evaluating the Diagnostic Role of the Testosterone-to-Prostate-Specific Antigen Ratio in Pre-Biopsy Risk Stratification of Prostate Cancer

<b>Background:</b> The testosterone-to-PSA (T/PSA) ratio has been proposed as a novel biomarker to enhance the diagnostic specificity of prostate-specific antigen (PSA) in prostate cancer (PCa) detection. The objective of this study was to evaluate the diagnostic performance of the T/PSA ratio in distinguishing PCa from benign conditions in men undergoing prostate biopsy. <b>Materials and Methods:</b> Eighty men who underwent systematic and targeted transrectal prostate biopsy were retrospectively studied. Clinical variables included serum PSA, testosterone, prostate volume, PSA density (PSAD), and the T/PSA ratio. Diagnostic accuracy was assessed using Receiver Operating Characteristic (ROC) curve analysis. Optimal cutoffs were determined using Youden's index. <b>Results:</b> PCa was diagnosed in 53 patients (66.3%). Median T/PSA was significantly lower in PCa versus non-PCa patients (0.46 vs. 0.86; <i>p</i> < 0.01). T/PSA showed good diagnostic performance (AUC = 0.75) with an optimal cutoff of 0.81 (sensitivity: 59.3%, specificity: 86.8%). In patients with PSA ≤10 ng/mL, T/PSA retained strong discriminatory ability (AUC = 0.76), with sensitivity and specificity of 82.4% and 72.7%, respectively. Among all parameters, PSAD showed the highest diagnostic accuracy (AUC = 0.813). T/PSA was not significantly associated with Gleason score (<i>p</i> = 0.48). <b>Conclusions:</b> The T/PSA ratio is a clinically accessible and cost-effective biomarker that may improve PCa risk stratification and reduce unnecessary biopsies, particularly in patients with borderline PSA levels. Although it does not correlate with tumor aggressiveness, its combination with PSAD could enhance diagnostic accuracy in routine clinical practice.