Purpose PSA and free PSA (fPSA) have limited specificity for detecting clinically significant, curable prostate cancer (PCa), leading to unnecessary biopsies and detection and treatment of some indolent tumors. [−2]proPSA (p2PSA) may improve specificity for detecting clinically significant PCa. Our objective was to evaluate p2PSA, fPSA, and PSA in a mathematical formula (prostate health index [phi] = [−2]proPSA / fPSA) × PSA1/2) to enhance specificity for detecting overall and high-grade PCa. Materials and Methods We enrolled 892 men in a prospective multi-institutional trial with no history of PCa, normal rectal examination, a PSA of 2–10 ng/mL, and ≥6- core prostate biopsy. We examined the relationship of serum PSA, %fPSA and phi with biopsy results. The primary endpoints were the specificity and AUC using phi to detect overall and Gleason ≥7 prostate cancer on biopsy compared with %fPSA. Results For the 2–10 ng/mL PSA range, at 80–95% sensitivity, the specificity and AUC (0.703) of phi exceeded those of PSA and %fPSA. Increasing phi was associated with a 4.7-fold increased risk of PCa and 1.61-fold increased risk of Gleason ≥7 disease on biopsy. The AUC for phi (0.724) exceeded that of %fPSA (0.670) in discriminating between PCa with Gleason ≥ 4+3 vs. lower grade disease or negative biopsies. Phi results were not associated with age and prostate volume. Conclusions Phi may be useful in PCa screening to reduce unnecessary biopsies in men age ≥50 years with PSA 2–10 ng/mL and negative DRE, with minimal loss in sensitivity.

Background: Prostate cancer gene 3 (PCA3) encodes a prostate-specific mRNA that has shown promise as a prostate cancer diagnostic tool. This report describes the characterization of a prototype quantitative PCA3-based test for whole urine. Methods: Whole-urine specimens were collected after digital rectal examination from 3 groups: men scheduled for prostate biopsy (n ‫؍‬ 70), healthy men (<45 years of age with no known prostate cancer risk factors; n ‫؍‬ 52), and men who had undergone radical prostatectomy (n ‫؍‬ 21). PCA3 and prostate-specific antigen (PSA) mRNAs were isolated, amplified, and quantified by use of Gen-Probe DTS400 ® Systems. Prostate biopsy results were correlated with the PCA3/PSA mRNA ratio, and PSA mRNA concentrations were used to normalize PCA3 signals and confirm the yield of prostate-specific RNA. Assay precision, specimen stability, and mRNA yield were also evaluated. Results: The specimen informative rate (fraction of specimens yielding sufficient RNA for analysis) was 98.2%. In this clinical research study, ROC curve analysis of prebiopsy specimens yielded an area under the curve of 0.746; sensitivity was 69% and specificity 79%. Serum PSA assay specificity was 28% for this same group. PCA3 and PSA mRNAs were undetectable in postprostatectomy specimens except for one man with recurrent prostate cancer. Assay interrun CVs were

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PCA3 is independent of prostate volume, serum prostate specific antigen level and the number of prior biopsies. The quantitative PCA3 score correlated with the probability of positive biopsy. Logistic regression results suggest that the PCA3 score could be incorporated into a nomogram for improved prediction of biopsy outcome. The results of this study provide further evidence that PCA3 is a useful adjunct to current methods for prostate cancer diagnosis.

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These preliminary data suggest that in aging men with late-onset hypogonadism, 6 months of TRT normalizes serum androgen levels but appears to have little effect on prostate tissue androgen levels and cellular functions. Establishment of prostate safety for large populations of older men undergoing longer duration of TRT requires further study. Trial Registration clinicaltrials.gov Identifier: NCT00161304.

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BACKGROUND To evaluate performance of magnetic resonance (MR)-ultrasound guided fusion biopsy in diagnosing clinically significant prostate cancer (csCaP). METHODS 1042 men underwent multi-parametric MRI (mpMRI) and fusion biopsy consecutively in a prospective trial (2009 – 2014). An expert reader graded mpMRI regions of interest (ROI) 1–5 using published protocols. The fusion biopsy device was used to obtain targeted cores from ROIs (when present) followed by a fusion-image guided 12-core systematic biopsy in all men, even if no suspicious ROI. Primary endpoint was detection of clinically significant CaP (i.e., Gleason score ≥ 7). RESULTS Among 825 men with ≥ 1 suspicious ROI of grade 3 or higher, 289 (35%) had csCaP. Powerful predictors of csCaP were ROI grade (grade 5 vs 3, OR 6.5, p<0.01) and prostate-specific antigen density (each increase of 0.05 ng/mL/cc, OR 1.4, p<0.01). Combining systematic and targeted biopsies detected more csCaP (n=289) than targeting (n=229) or systematic biopsy alone (n=199). Among patients with no suspicious ROI, 35 (16%) had csCaP on systematic biopsy. CONCLUSION In this prospective trial, MR-ultrasound fusion biopsy allowed detection of csCaP with a direct relationship with ROI grade and PSA density. The combination of targeted and systematic biopsy detected more csCaP than either modality alone; systematic biopsies revealed csCaP in 16% of men with no suspicious MRI target. Advantages of this new biopsy method are apparent, but issues of cost, training, and reliability await resolution prior to widespread adoption.