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Prostate cancer prognosisView Articles

Volume 17, Number 4Original Research

The 4Kscore® Test Reduces Prostate Biopsy Rates in Community and Academic Urology Practices

Jason HafronStephen M ZappalaDipen J ParekhDanielle OsterhoutJeffrey SchockRandy M ChudlerGregory M OldfordKenneth M KernenBadrinath R Konety

There is significant concern regarding prostate cancer screening because of the potential for overdiagnosis and overtreatment of men who are discovered to have abnormal prostate specific antigen (PSA) levels and/or digital rectal examination (DRE) results. The 4Kscore® Test (OPKO Diagnostics, LLC) is a blood test that utilizes four kallikrein levels plus clinical information in an algorithm to calculate an individual’s percentage risk (< 1% to > 95%) for aggressive prostate cancer (Gleason score ≥ 7) on prostate biopsy. The 4Kscore Test, as a follow-up test after abnormal PSA and/or DRE test results, has been shown to improve the specificity for predicting the risk of aggressive prostate cancer and reduce unnecessary prostate biopsies. A clinical utility study was conducted to assess the influence of the 4Kscore Test on the decision to perform prostate biopsies in men referred to urologists for abnormal PSA and/or DRE results. The study population included 611 patients seen by 35 academic and community urologists in the United States. Urologists ordered the 4Kscore Test as part of their assessment of men referred for abnormal PSA and/or DRE test results. Results for the patients were stratified into low risk (< 7.5%), intermediate risk (7.5%-19.9%), and high risk (≥ 20%) for aggressive prostate cancer. The 4Kscore Test results influenced biopsy decisions in 88.7% of the men. Performing the 4Kscore Test resulted in a 64.6% reduction in prostate biopsies in patients; the actual percentage of cases not proceeding to biopsy were 94.0%, 52.9%, and 19.0% for men who had low-, intermediate-, and high-risk 4Kscore Test results, respectively. A higher 4Kscore Test was associated with greater likelihood of having a prostate biopsy (P < 0.001). Among the 171 patients who had a biopsy, the 4Kscore risk category is strongly associated with biopsy pathology. The 4Kscore Test, as a follow-up test for an abnormal PSA and/or DRE results, significantly influenced the physician and patient shared decision in clinical practice, which led to a reduction in prostate biopsies while increasing the probability of detecting aggressive cancer. [Rev Urol. 2015;17(4):231-240 doi: 10.3909/riu0699] © 2016 MedReviews®, LLC

Prostate cancerProstate-specific antigen4KscoreGleason scoreDigital rectal examinationBiopsy rateProstate cancer prognosis

Prostate cancer, localizedView Articles

Volume 10, Number 4Review Articles

Vascular Targeted Photodynamic Therapy for Localized Prostate Cancer

Treatment Update

Herbert Lepor

Survival for men diagnosed with prostate cancer directly depends on the stage and grade of the disease at diagnosis. Prostate cancer screening has greatly increased the ability to diagnose small and low-grade cancers that are amenable to cure. However, widespread prostate-specific antigen screening exposes many men with low-risk cancers to unnecessary complications associated with treatment for localized disease without any survival advantage. One challenge for urological surgeons is to develop effective treatment options for low-risk disease that are associated with fewer complications. Minimally invasive ablative treatments for localized prostate cancer are under development and may represent a preferred option for men with low-risk disease who want to balance the risks and benefits of treatment. Vascular targeted photodynamic therapy (VTP) is a novel technique that is being developed for treating prostate cancer. Recent advances in photodynamic therapy have led to the development of photosynthesizers that are retained by the vascular system, which provides the opportunity to selectively ablate the prostate with minimal collateral damage to other structures. The rapid clearance of these new agents negates the need to avoid exposure to sunlight for long periods. Presented herein are the rationale and preliminary data for VTP for localized prostate cancer. [Rev Urol. 2008;10(4):254-261]

Vascular targeted photodynamic therapyPhotodynamic therapyProstate cancer, localizedMinimally invasive ablative treatment for prostate cancerWST-09WST-11PadoporfinPalladium bacteriopheophorbide

Prostate carcinomaView Articles
Prostate diagnostic or screening testView Articles

Volume 15, Number 3Review Articles

Prostate-Specific Antigen: Any Successor in Sight?

Diagnostic Review

Aniebietabasi S ObortMary B AjadiOluyemi Akinloye

Prostate cancer (PCa) is the most frequently diagnosed malignancy and the second leading cause of cancer death in men in the United States and other parts of the world. The lifetime risk of being diagnosed with PCa is approximately 16%. At present, the only widely accepted screening tools for PCa are prostate-specific antigen (PSA) and digital rectal examination. PSA is known to be prostate specific, but not PCa specific, and hence lacks the sensitivity to detect a large number of tumors, especially during the early stages. The PSA level is also known to be affected by many factors, such as medication, inflammation (benign prostatic hyperplasia and prostatitis), and urologic manipulation; hence, the controversy regarding the appropriate level of serum PSA that should trigger a biopsy or have clinical relevance to prostate metastases. Attempts to determine the level of prostate cells in peripheral blood by reverse transcriptase polymerase chain reaction did not significantly improve cancer diagnosis or predict postoperative failure. Therefore, the search continues for a novel biomarker or a panel of markers as well as other possible interventions to improve the use of PSA. This article reviews several possibilities. [Rev Urol. 2013;15(3):97-107 doi 10.3909/riu0567] © 2013 MedReviews®, LLC

Prostate-specific antigenProstate carcinomaProstate diagnostic or screening test

Prostate Health IndexView Articles

Volume 19, Number 4Review Articles

The Use of Biomarkers in Prostate Cancer Screening and Treatment

Treatment Update

Joseph Renzulli IIAshley V AlfordJoseph M Brito IIIKamlesh K YadavShalini S YadavAshutosh K Tewari

Prostate cancer screening and diagnosis has been guided by prostate-specific antigen levels for the past 25 years, but with the most recent US Preventive Services Task Force screening recommendations, as well as concerns regarding overdiagnosis and overtreatment, a new wave of prostate cancer biomarkers has recently emerged. These assays allow the testing of urine, serum, or prostate tissue for molecular signs of prostate cancer, and provide information regarding both diagnosis and prognosis. In this review, we discuss 12 commercially available biomarker assays approved for the diagnosis and treatment of prostate cancer. The results of clinical validation studies and clinical decision-making studies are presented. This information is designed to assist urologists in making clinical decisions with respect to ordering and interpreting these tests for different patients. There are numerous fluid and biopsy-based genomic tests available for prostate cancer patients that provide the physician and patient with different information about risk of future disease and treatment outcomes. It is important that providers be able to recommend the appropriate test for each individual patient; this decision is based on tissue availability and prognostic information desired. Future studies will continue to emphasize the important role of genomic biomarkers in making individualized treatment decisions for prostate cancer patients. [Rev Urol. 2017;19(4):221–234 doi: 10.3909/riu0772] © 2018 MedReviews®, LLC

Prostate cancerBiomarkers4KscoreProlarisPCA3Prostate Health IndexApifinyMichigan Prostate ScoreSelectMDxConfirmMDxProMarkPTEN/TMPRSS2:ERGDecipher

Prostate-specific antigen screeningView Articles

Volume 22, Number 3Review Articles

A Trend Toward Aggressive Prostate Cancer

Original Research

Navin ShahVladimir Ioffe

To compare prostate biopsy (Pbx) characteristics before and after the 2012 United States Preventive Services Task Force (USPSTF) prostate cancer (PCa) screening guidelines, we completed a retrospective comparative analysis of 1703 sequential patients that had a Pbx in 2010 to 2012 (3 years) with 383 patients biopsied in 2018 and 310 patients biopsied in 2019. Data was collected on patient age, race, serum prostate specific antigen (PSA) level, digital rectal examination (DRE) results, total number of biopsies performed, and Gleason sum score (GSS). Data were analyzed to determine whether the 2012 USPSTF screening recommendations against PCa screening may have affected PCa characteristics. Three study groups were defined as Group A, Group B, and Group C. Group A represents Pbx prior to the 2012 USPSTF screening guidelines (2010-2012), Group B represents Pbx in 2018, and Group C represents Pbx in 2019. The patient population consisted of 73% Black men, 16% White men, and 11% men of other races. The number of patients that had a biopsy in Groups A through C, respectively, were 567 patients/year, 383 patients/year, and 310 patients/year. The annual positive Pbx rate for Group A through C was 134/year, 175/year, and 201/year, respectively. High-grade PCa (GSS 7-10) in Groups A through C was 51.5%, 60.5%, and 60.0%. The proportion of patients with a serum PSA level 10 ng/mL or greater in Groups A through C was 25.4%, 29.3%, and 33%. For patients age 70 to 80 years, there was an increasing trend for serum PSA levels 10 ng/mL and higher: 31%, 38%, and 39%, respectively. In this age group, high-grade tumors (GSS 7-10) occurred in 61%, 65%, and 68%, respectively. In 2019, Grade Group 3, 4, and 5 was present in 37.7% of 70- to 80-year-old men and 34.6% of Black men. More than 50% positive biopsy cores were present in 46.3% of 70- to 80-year-old men and 36.6% of Black men. Our data through 2019 continued to show that after the 2012 USPSTF recommendations against PCa screening, PCa screening has decreased. We found decreased Pbx, increased PCa diagnosis, and increased high-grade PCa (GSS 7-10). As our patient population consisted of 73% Black patients and 33% of men age 70 to 80 years, our results support aggressive PCa screening for high-risk patients, which include Black men, men with a family history of PCa, and healthy men age 70 to 80 years. [Rev Urol. 2020;22(3):102-109] © 2020 MedReviews®, LLC

Prostate cancerElderly menUnited States Preventive Services Task ForceProstate-specific antigen screeningBlack men