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Rana R. McKayView Articles

Volume 23, Number 3Prostate Cancer

Darolutamide for the Management of Metastatic Hormone-Sensitive Prostate Cancer: A Urologist-Oncologist Perspective

Paul DatoRana R. McKay

Metastatic prostate cancer accounts for 8% of all prostate cancer cases in the United States and has an estimated 5-year survival rate of 34%. Androgen-deprivation therapy (ADT) is the cornerstone of treatment for men with metastatic hormone-sensitive prostate cancer (HSPC), but there has been a recent focus on early treatment intensification through dual- or triple-therapy approaches, which have shown substantial survival benefit compared with ADT alone. Darolutamide, a distinct androgen receptor inhibitor, is the latest treatment for men with metastatic HSPC. In the Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer (ARASENS) trial (ClinicalTrials.gov identifier NCT02799602), darolutamide in combination with ADT and docetaxel reduced the risk of death by 32.5% (P < .001) compared with ADT plus docetaxel in men with metastatic HSPC. The most recent National Comprehensive Cancer Network guidelines (2023) support the use of triple-therapy regimens for men with high-volume metastatic HSPC, but concerns about the side effects of the short-term chemotherapy component of this regimen necessitate a comprehensive approach to providing supportive care to ensure that patients are willing to begin and remain on treatment. Effective management should involve a well-informed multidisciplinary team with patient education and support to ensure optimal treatment outcomes. Here, we review the results of the ARASENS trial and consider the implications for the management of metastatic HSPC. By showing a statistically significant reduction in risk of death, triple therapy combining darolutamide with ADT and docetaxel has emerged as a new treatment modality that may help men with metastatic HSPC achieve prolonged survival while maintaining an acceptable quality of life.

Prostatic neoplasmsDrug therapyNeoplasm metastasisAndrogen receptor antagonists

Randy M ChudlerView 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&rsquo;s percentage risk (&lt; 1% to &gt; 95%) for aggressive prostate cancer (Gleason score &ge; 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 (&lt; 7.5%), intermediate risk (7.5%-19.9%), and high risk (&ge; 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 &lt; 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