To assess the clinical performance of ProsTAV®, a blood-based test based on telomere associate variables (TAV) measurement, to support biopsy decision-making when diagnosing suspicious prostate cancer (PCa).
Preliminary data of a prospective observational pragmatic study of patients with prostate-specific antigen (PSA) levels 3-10 ng/ml and suspicious PCa. Results were combined with other clinical data, and all patients underwent prostate biopsies according to each center's routine clinical practice, while magnetic resonance imaging (MRI) before the prostate biopsy was optional. Sensitivity, specificity, positive and negative predicted values, and subjects where biopsies could have been avoided using ProsTAV were determined.
The mean age of the participants (n = 251) was 67.4 years, with a mean PSA of 5.90 ng/ml, a mean free PSA of 18.9%, and a PSA density of 0.14 ng/ml. Digital rectal examination was abnormal in 21.1% of the subjects, and according to biopsy, the prevalence of significant PCa was 47.8%. The area under the ROC curve of ProsTAV was 0.7, with a sensitivity of 0.90 (95% CI, 0.85-0.95) and specificity of 0.27 (95% CI, 0.19-0.34). The positive and negative predictive values were 0.53 (95% CI, 0.46-0.60) and 0.74 (95% CI, 0.62-0.87), respectively. ProsTAV could have reduced the biopsies performed by 27% and showed some initial evidence of a putative benefit in the diagnosis pathway combined with MRI.
ProsTAV increases the prediction capacity of significant PCa in patients with PSA between 3 and 10 ng/ml and could be considered a complementary tool to improve the patient diagnosis pathway.
World journal of urology. 2024 Jul 10*** epublish ***
Enrique Gómez-Gómez, Juan Ignacio Martínez-Salamanca, Fernando Bianco, Brian J Miles, Javier Burgos, Juan Justo Quintas, Roque Cano-Castiñeira, Álvaro Gómez-Ferrer, Alfredo Rodríguez-Antolín, Gilberto Chéchile, Luis Fernández, Almudena Martín, Paloma Hidalgo, Mónica Parramón
Department of Urology, Hospital Universitario Reina Sofía, Universidad de Córdoba, IMIBIC, Córdoba, Spain., LYX Urology Institute, Madrid, Spain., Urological Research Network, Miami Lakes, FL, USA., Urologic Oncology, Houston Methodist Hospital, Houston, TX, USA., Department of Urology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain., ROC Clinic y HM Hospitales, Madrid, Spain., IVO Instituto Valenciano de Oncología (IVO), Valencia, Spain., Department of Urology, Hospital Universitario Doce de Octubre, Madrid, Spain., Instituto Médico Tecnológico, Barcelona, Spain., Life Length, S.L., Madrid, Spain., Life Length, S.L., Madrid, Spain. .