Factors associated with false negative and false positive results of prostate-specific antigen (PSA) and the impact on patient health

Abstract

Introduction:Prostate-specific antigen (PSA) is the main tool for early detection, risk stratification and monitoring of prostate cancer (PCa). However, there are controversies about the use of PSA as a population screening test because of the high potential for overdiagnosis and overtreatment associated. The net benefit of screening is unclear and according to the available recommendations, it should be offered to well-informed men with an adequate health status and a life-expectancy of at least 10 years or to men at elevated risk of having PCa. In addition, the factors that influence test results are unclear, as is impact of false positive or negative results on patient health.Our objective is to assess the clinical and analytical factors associated with the presence of false positive and false negative results and the diagnostic/therapeutic process followed by these patients.Methods and analysis:A prospective observational cohort study will be carried out. We will include a cohort of patients with a positive PSA result (1.081 patients) and a sample of patients with negative results (572 patients); both will be followed for 2 years by reviewing medical records to assess the variables associated with these results, as well as characteristics of patient management after a positive PSA value. We will include those patients with a PSA determination from 2 hospitals in the Valencian Community. Patients who have been previously diagnosed with prostate cancer or who are being followed for previous high PSA values will be excluded.Discussion:The study will estimate the frequency of false positive and false negative PSA results in routine clinical practice, and allow us to quantify the potential harm caused.Study registration:Clinicaltrials.gov (https://clinicaltrials.gov/): NCT03978299, June 7, 2019.

Multiparametric MRI may Help to Identify Patients With Prostate Cancer in a Contemporary Cohort of Patients With Clinical Bladder Outlet Obstruction Scheduled for Holmium Laser Enucleation of the Prostate (HoLEP)

“…Second, standard PCa evaluation using (total) serum PSA measurement cannot reliably identify patients with underlying PCa who are presenting with clinical BOO. Potentially, enlargement of the prostate, urinary retention, or indwelling transurethral catheters as well as others represent confounding factors limiting the validity of this otherwise helpful clinical tool (4,(12)(13)(14)(15)(16). Interestingly, also after accounting for prostate volume using PSA density, no clinical or statistically meaningful differences between patients with malignant and benign BOO were observed.…”

Patient-centered Weight Tracking as an Early Cancer Detection Strategy

“…Therefore, UWL screening could be the first universal early detection method. In contrast to some traditional cancer detection strategies (mammogram, prostate-specific antigen), there are essentially no false positives [ 31 , 32 ]. Although an underlying etiology cannot be determined in approximately 20% of UWL cases [ 1 - 9 ], most instances are believed to result from some abnormal pathology (cancer or a benign disease process).…”

Predictive value of standard serum markers for bone metastases in prostate cancer

“…The most important marker used to decide which patients should be considered for biopsy is the serum prostate-specific antigen (PSA) value [1][2][3]. However, PSA, which is a glycoprotein produced by the prostate tissue, increases not only in the case of prostate cancer but also in the case of a variety of benign diseases such as benign prostate hypertrophy (BPH), prostatitis and urinary infections [4]. In addition, the specificity and positive predictive value of PSA, as a commonly used marker in prostate cancer screening, is low and an exact cutoff value has not yet been defined [5].…”