A randomized study of apalutamide in Chinese patients with non-metastatic castration-resistant prostate cancer.

This post-approval commitment study addressed the limited data on the safety and efficacy of apalutamide in Chinese patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). Utilizing a double-blinded, placebo-controlled trial with pre-planned crossover design, 75 patients were randomized (2:1) to receive apalutamide 240 mg daily or placebo while continuing androgen deprivation therapy. Apalutamide significantly reduced the risk of prostate-specific antigen (PSA) progression by 76.

A Framework for Advancing Colorectal Cancer Screening, Follow-Up, and Care Delivery for All.

Increasing colorectal cancer (CRC) screening requires delivery and adaptation of evidence-based and theory-guided interventions. The Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) consortium is funded by the National Cancer Institute, with a primary goal of increasing the availability and use of approaches to CRC prevention and control, from screening through follow-up testing, diagnosis, and referral to care. In this article, we present a framework for improving CRC, follow-up, and referral to care among populations that have low CRC screening rates.

Digital Pathology-Based Multimodal Artificial Intelligence Scores and Outcomes in a Randomized Phase III Trial in Men With Nonmetastatic Castration-Resistant Prostate Cancer.

Purpose: The SPARTAN trial demonstrated that the addition of apalutamide to androgen deprivation therapy improves outcomes among patients with nonmetastatic castration-resistant prostate cancer (nmCRPC). We applied a previously reported digital histopathology-based multimodal artificial intelligence (MMAI) algorithm to estimate clinical outcomes in SPARTAN.

Methods: Patients with available hematoxylin and eosin-stained slides from the primary tumor were included.

Post-Metastasis Survival of Patients with High-Risk Localized and Locally Advanced Prostate Cancer Undergoing Primary Treatment in the United States: A Retrospective Study.

Background: Patients with high-risk localized and locally advanced prostate cancer (HR-LPC/LAPC) have increased risk of metastasis, leading to reduced survival rates. Segmenting the disease course [time to recurrence, recurrence to metastasis, and post-metastasis survival (PMS)] may identify disease states for which the greatest impacts can be made to ultimately improve survival.

Objective: Evaluate real-world PMS of patients with HR-LPC/LAPC who received primary radical prostatectomy (RP) or radiotherapy (RT) with or without androgen deprivation therapy (ADT).

Prostate-specific antigen and health-related quality of life in individuals with advanced prostate cancer treated with apalutamide: a plain language summary of the SPARTAN and TITAN studies.

What Is This Summary About?: This is a summary of a paper that describes the results of the SPARTAN and TITAN studies, which looked at whether a treatment called apalutamide can help treat individuals with advanced prostate cancer.The SPARTAN study included 1207 participants with nonmetastatic castration-resistant prostate cancer (or nmCRPC). The TITAN study included 1052 participants with metastatic castration-sensitive prostate cancer (or mCSPC).

Targeted Investigational Treatment Analysis of Novel Anti-androgen (TITAN) study: ultralow prostate-specific antigen decline with apalutamide plus androgen-deprivation therapy.

Objective: To assess the association between achievement of prostate-specific antigen (PSA) levels ≤0.2 ng/mL (henceforth 'ultralow') and clinical outcomes in patients in the 'Targeted Investigational Treatment Analysis of Novel Anti-androgen' (TITAN) study (ClinicalTrials.gov Identifier NCT02489318) with metastatic castration-sensitive prostate cancer (mCSPC).

Influential Factors Impacting Treatment Decision-making and Decision Regret in Patients with Localized or Locally Advanced Prostate Cancer: A Systematic Literature Review.

Context: Treatment decision-making (TDM) for patients with localized (LPC) or locally advanced (LAPC) prostate cancer is complex, and post-treatment decision regret (DR) is common. The factors driving TDM or predicting DR remain understudied.

Objective: Two systematic literature reviews were conducted to explore the factors associated with TDM and DR.

Prostate-specific antigen (PSA) decline with apalutamide therapy is associated with longer survival and improved outcomes in individuals with metastatic prostate cancer: a plain language summary of the TITAN study.

What Is This Summary About?: This summary describes the results from an additional (or post hoc) analysis of the TITAN study. The TITAN study looked at whether the prostate cancer treatment apalutamide could be used to treat individuals with metastatic castration-sensitive prostate cancer (or mCSPC). A total of 1052 participants with mCSPC were included in the TITAN study.

Post Hoc Analysis of Rapid and Deep Prostate-specific Antigen Decline and Patient-reported Health-related Quality of Life in SPARTAN and TITAN Patients with Advanced Prostate Cancer.

Background: Adding apalutamide to androgen-deprivation therapy (ADT) resulted in a rapid (at 3- and 6-mo treatment) and deep prostate-specific antigen (PSA) decline (to ≤0.2 ng/ml or ≥90% from baseline), improved overall survival, reduced risk of disease progression, and prolonged health-related quality of life (HRQoL) in nonmetastatic castration-resistant prostate cancer (nmCRPC) in SPARTAN and metastatic castration-sensitive PC (mCSPC) in TITAN.

Objective: To evaluate the association of a rapid, deep PSA decline at 3 and 6 mo achieved with the addition of apalutamide to ADT with patient-reported outcomes (PROs) in SPARTAN and TITAN.

Apalutamide efficacy, safety and wellbeing in older patients with advanced prostate cancer from Phase 3 randomised clinical studies TITAN and SPARTAN.

Background: Apalutamide plus androgen-deprivation therapy (ADT) improved outcomes in metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-resistant PC (nmCRPC) in the Phase 3 randomised TITAN and SPARTAN studies, respectively, and maintained health-related quality of life (HRQoL). Apalutamide treatment effect by patient age requires assessment.

Methods: Post-hoc analysis assessed patients receiving 240 mg/day apalutamide (525 TITAN and 806 SPARTAN) or placebo (527 TITAN and 401 SPARTAN) with ongoing ADT, stratified by age groups.

Apalutamide plus androgen deprivation therapy in clinical subgroups of patients with metastatic castration-sensitive prostate cancer: A subgroup analysis of the randomised clinical TITAN study.

Background: Whether disease burden in patients with metastatic castration-sensitive prostate cancer (mCSPC) predicts treatment outcomes is unknown. We assessed apalutamide treatment effect in TITAN patients with mCSPC by disease volume, metastasis number and timing of metastasis presentation.

Methods: These protocol-defined and post hoc analyses of the phase III randomised TITAN study evaluated clinical outcomes in patients receiving 240 mg/day apalutamide (n = 525) or placebo (n = 527) plus androgen-deprivation therapy (ADT).

Apalutamide for metastatic castration-sensitive prostate cancer: final analysis of the Asian subpopulation in the TITAN trial.

The final analysis of the phase 3 Targeted Investigational Treatment Analysis of Novel Anti-androgen (TITAN) trial showed improvement in overall survival (OS) and other efficacy endpoints with apalutamide plus androgen deprivation therapy (ADT) versus ADT alone in patients with metastatic castration-sensitive prostate cancer (mCSPC). As ethnicity and regional differences may affect treatment outcomes in advanced prostate cancer, a post hoc final analysis was conducted to assess the efficacy and safety of apalutamide in the Asian subpopulation. Event-driven endpoints were OS, and time from randomization to initiation of castration resistance, prostate-specific antigen (PSA) progression, and second progression-free survival (PFS2) on first subsequent therapy or death.

Breast cancer knowledge & information seeking among African American women below screening age.

Objectives: African American women below screening age disproportionately face greater mortality from breast cancer relative to peers of other races and African American women of screening age. The current study examines breast cancer knowledge and health information seeking of African American women below screening age.

Methods: We collected survey data from 99 African American women below screening age on their breast cancer knowledge and health information seeking behaviors.

Randomized, Open-Label Phase 2 Study of Apalutamide plus Androgen Deprivation Therapy versus Apalutamide Monotherapy versus Androgen Deprivation Monotherapy in Patients with Biochemically Recurrent Prostate Cancer.

Purpose: This randomized phase 2 study sought to assess the treatment effect of a finite duration of apalutamide with and without androgen deprivation therapy (ADT) in biochemically recurrent prostate cancer (BCR PC). Patients with BCR PC after primary definitive therapy and prostate-specific antigen (PSA) doubling time ≤12 months were randomized to open-label apalutamide (240 mg/d) alone, apalutamide plus ADT, or ADT alone (1 : 1:1 ratio) for 12 months followed by a 12-month observation period (NCT01790126). Mean changes from baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) at 12 months (primary endpoint) and other prespecified assessments of health-related quality of life (HRQoL), PSA nadir, time to PSA progression, time to testosterone recovery, recovered testosterone >150 ng/dL without PSA progression at 24 months, and molecular markers were evaluated.

Barriers and Enablers to Implementing Peer Specialists in Veterans Health Administration Primary Care: a Qualitative Study.

Background: Peer specialists (PSs) are increasingly deployed in a variety of settings to provide patient-centered care. In the Veterans Health Administration (VHA), efforts are underway to integrate PSs into primary care settings. Little is known about the barriers and enablers to implementing PS services in primary care.

Current State of Funded National Cancer Institute Grants That Include Economic Analyses.

Background: Health economics research is an integral part of the transdisciplinary research supported by the National Cancer Institute (NCI). To better understand NCI activities in this area, we conducted a portfolio analysis of funded NCI grants including health economics research.

Methods: We examined all competitive grants funded by NCI from fiscal years 2015 to 2020 that included economic analyses or outcomes.

Peer specialists deliver cognitive behavioral social skills training compared to social skills training and treatment as usual to veterans with serious mental illness: study protocol for a randomized controlled trial.

Background: Serious mental illness (SMI) affects 4.6% of the American population. While treatments are available, adherence to specific regimens is often suboptimal.

Efficacy and safety exposure-response relationships of apalutamide in patients with metastatic castration-sensitive prostate cancer: results from the phase 3 TITAN study.

Purpose: Apalutamide plus androgen-deprivation therapy (ADT) has been approved for treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) based on data from phase 3 TITAN study. This analysis was conducted to describe pharmacokinetics of apalutamide and N-desmethyl-apalutamide and explore relationships between apalutamide exposure and selected clinical efficacy and safety observations.

Methods: 1052 patients were randomized to apalutamide + ADT (n = 525) or placebo + ADT (n = 527).

Safety and efficacy of apalutamide in Japanese patients with metastatic castration-sensitive prostate cancer receiving androgen deprivation therapy: Final report for the Japanese subpopulation analysis of the randomized, placebo-controlled, phase III TITAN study.

Objectives: The TITAN study is a randomized, double-blind, placebo-controlled, multinational trial that evaluated apalutamide with androgen deprivation therapy in patients with metastatic castration-sensitive prostate cancer. At the first interim analysis in the Japanese subpopulation (median follow-up 25.7 months), there was an improvement in overall survival and radiological progression-free survival with apalutamide versus placebo.

Concomitant use of oral anticoagulants in patients with advanced prostate cancer receiving apalutamide: A post-hoc analysis of TITAN and SPARTAN studies.

Apalutamide, an androgen receptor signaling inhibitor, in combination with androgen-deprivation therapy (ADT), is approved for treatment of patients with nonmetastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer, based on the data from the phase 3 SPARTAN and TITAN studies respectively. Apalutamide is an inducer of cytochrome P450 enzymes and P-glycoprotein, which are involved in the metabolism of oral anticoagulants (OACs) and may thus have potential drug-drug interactions when co-administered with OACs. Concomitant use of certain OACs such as apixaban, rivaroxaban, edoxaban, dabigatran, and warfarin was allowed in the SPARTAN and TITAN studies.

Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 study.

Background: The majority of patients with metastatic castration-resistant prostate cancer (mCRPC) will have disease progression of a uniformly fatal disease. mCRPC is driven by both activated androgen receptors and elevated intratumoural androgens; however, the current standard of care is therapy that targets a single androgen signalling mechanism. We aimed to investigate the combination treatment using apalutamide plus abiraterone acetate, each of which suppresses the androgen signalling axis in a different way, versus standard care in mCRPC.