The FDA has approved three androgen receptor inhibitors-enzalutamide, apalutamide, and darolutamide-for the treatment of patients with nonmetastatic castration-resistant prostate cancer (nmCRPC). These approvals were all based on randomized, double blind, placebo-controlled trials demonstrating large improvements in metastasis-free survival (MFS) and internally consistent evidence of benefit seen across secondary endpoints. In this article, we summarize the FDA regulatory history of MFS and we describe the design, conduct, and results of the three pivotal trials supporting these important treatment options for patients with nmCRPC.
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Current Status of Neoadjuvant Treatment Before Surgery in High-Risk Localized Prostate Cancer.
Cancers (Basel)
December 2024
Urology Department, Hospital Clínico San Carlos, 28040 Madrid, Spain.
Localized high-risk (HR) prostate cancer (PCa) is a heterogeneous disease whose likelihood of a biochemical recurrence, metastatic progression and cancer-related mortality after initial treatment is higher when compared with patients with low (LR) or intermediate-risk (IR) disease. In the past, neoadjuvant therapy has shown an improvement in postoperative oncological variables but failed to demonstrate any survival advantages. With the promising results from novel treatments in metastatic and non-metastatic castration resistant PCa settings, new evidence has appeared in the literature in the neoadjuvant setting.
View Article and Find Full Text PDFDarolutamide in Combination with Radium-223 Exhibits Synergistic Antitumor Efficacy in LNCaP Prostate Cancer Models.
Int J Mol Sci
December 2024
Bayer AG, Research & Development, Pharmaceuticals, 13353 Berlin, Germany.
Despite treatment, prostate cancer commonly progresses into castration-resistant prostate cancer (CRPC), which remains largely incurable, requiring the development of new interventions. Darolutamide is an orally administered second-generation androgen receptor inhibitor indicated for patients with non-metastatic CRPC or metastatic hormone-sensitive prostate cancer. Here, we evaluated the effect of androgen receptor (AR) inhibition by darolutamide in combination with DNA double-strand-break-inducing targeted radium-223 alpha therapy in vitro and in an intratibial LNCaP xenograft model mimicking prostate cancer metastasized to bone.
View Article and Find Full Text PDFReal-world Clinical Outcomes and Prognostic Factors in Neuroendocrine Prostate Cancer.
Clin Genitourin Cancer
November 2024
Tom Baker Cancer Centre, Calgary, Alberta, Canada.
Background: Neuroendocrine prostate cancer (NEPC) encompasses pure NEPC and tumors with mixed adenocarcinoma and neuroendocrine histology. While NEPC is thought to confer a poor prognosis, outcome data are sparse, making risk stratification and treatment decisions difficult for clinicians.
Methods: This retrospective study identified patients with morphological and/or immunohistochemical NEPC features on pathological review of high-grade prostate cancer cases.
High 11-Ketotestosterone Linked to Shorter Time to Castration Resistance in Recurrent Nonmetastatic Prostate Cancer.
J Urol
November 2024
Centre de recherche du Centre Hospitalier Universitaire de Québec-Université Laval (CHU de Québec Research Centre-UL), Centre de recherche en cancer (CRC) de l'Université Laval and Faculty of Pharmacy, Université Laval, Quebec, Canada.
Article Synopsis
- The study investigates the role of 11-oxygenated androgens, particularly 11-ketotestosterone (11KT), in predicting the progression of lethal prostate cancer and the onset of castration-resistant prostate cancer (CRPC).
- Using mass spectrometry on blood samples from 145 patients treated with androgen deprivation therapy, researchers analyzed the relationship between androgen levels and CRPC development.
- Findings suggest higher levels of 11KT are associated with a shorter time to CRPC, indicating that monitoring this hormone could enhance treatment strategies for prostate cancer patients.
Racial and Ethnic Differences in Prostate Cancer Epidemiology Across Disease States in the VA.
JAMA Netw Open
November 2024
Department of Surgery, Durham VA Health Care System, Durham, North Carolina.
Importance: Prostate cancer (PC) care has evolved rapidly as a result of changes in prostate-specific antigen testing, novel imaging, and newer treatments. The impact of these changes on PC epidemiology and racial disparities across disease states remains underexplored.
Objective: To characterize racial and ethnic differences in the epidemiology of PC states, including nonmetastatic hormone-sensitive PC (nmHSPC), metastatic HSPC (mHSPC), nonmetastatic castration-resistant PC (nmCRPC), and metastatic CRPC (mCRPC).
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