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Abstract
BackgroundFinasteride, a 5-alpha reductase inhibitor may have effects on biomarkers such as prostate-specific antigen (PSA) that could be leveraged to improve screening.ObjectiveTo determine the predictive characteristics of biomarkers for prostate cancer for cancer on biopsy following 3 months of finasteride use compared with placebo.Design, setting and participants383 men from multiple clinical sites with intermediate prostate cancer risk, without history of prostate cancer, were randomly allocated in a double-blinded manner, 4:1, to receive either finasteride or placebo for 90 days at which time a prostate biopsy was performed.Outcome measurements and statistical analysisThe primary outcomes were associations of biomarkers with prostate cancer that were tested using multiple logistic regression and area under the receiver operating curves (AUC). Biomarkers for PCA risk (PCA3, TMPRSS2:ERG (T2:ERG) gene product, and PSA) were measured at baseline and at biopsy in a blinded fashion to assess the predictive performance of baseline levels, 90-day levels, and measures of change relative to standard predictors.Results and limitationsA total of 292 (233 finasteride; 59 placebo) randomized patients underwent biopsy and were analyzed. On finasteride, baseline and 90-day measures of PCA3 and T2:ERG had similar moderate discrimination capacity with AUCs 62 to 65% (p-values < 0.001 and 0.001, respectively), but their rates of change had no discrimination ability (AUC 51%, (95% CI 43 to 60% p = 0.72) and 48% (95% CI 44 to 60%, p = 0.62), respectively).) Relative to baseline, the 90-day PCA3 and PSA decreased in the finasteride group by 25% and 50%, respectively (both p<0.001). T2:ERG had a smaller, non-significant change post finasteride treatment (p = 0.08).ConclusionsShort-term finasteride therapy did not improve performance of the most commonly-employed prostate cancer biomarkers. Threshold values for new biomarkers of prostate cancer should be interpreted with caution in patients receiving finasteride until formal validation of test performance in these patients is conducted.Patient summaryThree months of finasteride treatment did not increase the accuracy for predicting the outcome on prostate biopsy but did have a significant effect on biomarker values. Adjustments to thresholds for biopsy for men on finasteride are proposed.Trial registrationClinicalTrials.gov, NCT01296672.
Highlights
Prostate cancer (PCA) is the most common non-cutaneous cancer in men living in the United States
Baseline and 90-day measures of Prostate cancer antigen 3 (PCA3) and T2:ERG had similar moderate discrimination capacity with area under the receiver operating curves (AUC) 62 to 65% (p-values < 0.001 and 0.001, respectively), but their rates of change had no discrimination ability (AUC 51%, and 48%, respectively).) Relative to baseline, the 90-day PCA3 and prostatespecific antigen (PSA) decreased in the finasteride group by 25% and 50%, respectively
Threshold values for new biomarkers of prostate cancer should be interpreted with caution in patients receiving finasteride until formal validation of test performance in these patients is conducted
Summary
Prostate cancer (PCA) is the most common non-cutaneous cancer in men living in the United States. Improvements in diagnosis are necessary, and there are promising biomarkers that have evidence for improving screening accuracy Included among these are the noncoding RNA known as Prostate cancer antigen 3 (PCA3) [7] and TMPRSS2:ERG (T2:ERG) fusion gene. ERG is a member of the Erythroblast Transformation-Specific (ETS) gene family and is commonly fused in prostate cancer to the TMPRSS2 gene (Transmembrane Protease, Serine 2)[8]. These markers are measured by quantitating the level of their RNA transcripts in post-DRE (digital rectal examine) urine from subjects normalized against PSA transcripts. Finasteride, a 5-alpha reductase inhibitor may have effects on biomarkers such as prostatespecific antigen (PSA) that could be leveraged to improve screening
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