Impact of treatment suspension on health-related quality of life in the EMBARK trial: a post hoc analysis.

Background: Enzalutamide was approved for high-risk biochemically recurrent (hrBCR) prostate cancer based on the EMBARK trial (NCT02319837; 17 December 2014-31 January 2023). In EMBARK, treatment was suspended at week 37 if prostate-specific antigen (PSA) was <0.2 ng/mL and reinstated if PSA rose to ≥2.

Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer With UGN-102: Outcomes From the 5-Year Long-Term Extension Study of the Single-Arm, Phase 2b Optima II Study.

Introduction: The OPTIMA II phase 2b study (NCT03558503) treated patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) with UGN-102, a reverse thermal hydrogel containing mitomycin. Efficacy and safety results have been reported for the 12-month parent study; here, we report 5-year follow-up data.

Patients And Methods: Patients who participated in the OPTIMA II study and achieved a complete response (CR) after 6 weekly doses of UGN-102 were followed for up to 9 months after initial CR.

Transcriptome profiling of prostatic tumours from ENACT trial patients with or without enzalutamide.

Objectives: To evaluate the longitudinal transcriptomic changes that occurred over time in patients from the ENACT trial (ClinicalTrials.gov identifier: NCT02799745). ENACT evaluated patients with low- or intermediate-risk prostate cancer, comparing the efficacy and safety of enzalutamide plus active surveillance (AS) to AS alone.

Talazoparib plus enzalutamide in men with metastatic castration-resistant prostate cancer: final overall survival results from the randomised, placebo-controlled, phase 3 TALAPRO-2 trial.

Background: The primary analysis of this phase 3 trial combining talazoparib with enzalutamide demonstrated significantly improved radiographic progression-free survival (rPFS) versus enzalutamide plus placebo in patients with metastatic castration-resistant prostate cancer unselected for homologous recombination repair (HRR) gene alterations. Overall survival data were immature at that time. Here we report the final prespecified overall survival analysis, an updated descriptive analysis of rPFS, and safety in the cohort unselected for HRR gene alterations.

Talazoparib plus enzalutamide in men with HRR-deficient metastatic castration-resistant prostate cancer: final overall survival results from the randomised, placebo-controlled, phase 3 TALAPRO-2 trial.

Background: Metastatic castration-resistant prostate cancer remains incurable and is particularly aggressive in patients with alterations in DNA damage repair genes involved directly or indirectly in homologous recombination repair (HRR). In the primary analysis of TALAPRO-2, talazoparib plus enzalutamide significantly improved radiographic progression-free survival (rPFS) versus enzalutamide plus placebo in patients with metastatic castration-resistant prostate cancer harbouring HRR gene alterations. At primary analysis, overall survival was immature.

Healthcare resource utilization and costs among patients with metastatic castration-sensitive prostate cancer initiated on apalutamide or enzalutamide in the United States (2019-2023).

Aims: This retrospective longitudinal cohort study compared healthcare resource utilization (HRU) and costs among patients with metastatic castration (hormone)-sensitive prostate cancer who initiated apalutamide or enzalutamide, two androgen receptor pathway inhibitors (ARPIs) that have demonstrated efficacy in the treatment of advanced prostate cancer in phase 3 clinical trials.

Methods: Linked patient-level data from a practice-related clinical urology database and an administrative claims database in the United States (1 January 2016-31 December 2023) were used. Per-patient-per-month (PPPM) HRU and cost outcomes were compared between the apalutamide and enzalutamide cohorts during the observation period (i.

Intravesical interferon-α2b gene therapy with nadofaragene firadenovec-vncg: a contemporary review.

Intravesical bacillus Calmette-Guerin (BCG) represents the standard of care therapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC); however, the rate of BCG-unresponsive disease remains high. Cystectomy is the most definitive treatment for patients with this disease entity but is associated with significant morbidity and quality-of-life implications. Recently, several single-arm clinical trials have been conducted to develop alternative treatment options for patients who are ineligible for or decline cystectomy based on guidance from the US Food and Drug Administration (FDA).

Enzalutamide treatment of patients with advanced prostate cancer across the disease spectrum: plain language review.

Goal: To present data from published clinical trials of treatment of patients with prostate cancer with enzalutamide described in plain language and in a dashboard format available at: https://clinical-trials.dimensions.ai/enzalutamide-clinical-review/.

A Podcast on Integrating Genetic Testing for Homologous Recombination Repair Gene Alterations in Patients with Prostate Cancer in the USA: a Multidisciplinary Approach to Overcoming the Obstacles.

Homologous recombination repair (HRR) gene alterations in prostate cancer predispose patients to more aggressive disease and a poorer prognosis. The presence of these HRR gene alterations may inform patient eligibility for clinical trials and targeted therapies, and importantly, through cascade testing, help identify family members at risk of developing an inherited cancer. This finding highlights the importance of testing for HRR gene alterations in patients with prostate cancer.

rechARge: a randomized phase III trial of the androgen receptor ligand-directed degrader, BMS-986365, vs investigator's choice in patients with mCRPC.

There is an ongoing need for efficacious, life-prolonging therapies for males with metastatic castration-resistant prostate cancer (mCRPC). mCRPC that progresses after treatment with androgen receptor pathway inhibitors (ARPIs) may still be driven by AR signaling. BMS-986365 is a heterobifunctional, orally bioavailable ligand-directed degrader that targets the AR through a first-in-class dual mechanism of AR degradation and antagonism.

Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: the randomized phase 3 CREST trial.

Bacillus Calmette-Guérin (BCG) induction and maintenance (I+M) after transurethral resection of bladder tumor is standard of care (SOC) in high-risk non-muscle invasive bladder cancer (NMIBC). However, disease recurrence/progression occurs in approximately 40% of patients at 2 years, with unfavorable prognosis. Limited bladder-sparing therapeutic options exist, and no improvements to response durability have been observed in decades.

Health-related quality of life, pain, and symptomatic skeletal events with [Lu]Lu-PSMA-617 in patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): an open-label, randomised, phase 3 trial.

Background: In the PSMAfore study, lutetium-177 [Lu]Lu-PSMA-617 (vipivotide tetraxetan) significantly improved radiographic progression-free survival compared with change of androgen receptor pathway inhibitor (ARPI) in taxane-naive patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer. Here, we present in-depth analyses of time to worsening of health-related quality of life (HRQOL) and pain, and time to first symptomatic skeletal events.

Methods: PSMAfore, an open-label, randomised, phase 3 trial, was conducted at 74 investigator sites (including hospitals with nuclear medicine departments and the research facilities where patients were recruited) across 14 countries.

Overall Survival with Apalutamide Versus Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer.

Introduction: Survival outcomes associated with different androgen receptor pathway inhibitors (ARPIs) prescribed for the treatment of metastatic castration (hormone)-sensitive prostate cancer (mCSPC) have not been directly compared. The objective of this study was to compare overall survival (OS) by 24 months among ARPI-naïve patients with mCSPC initiating apalutamide or enzalutamide.

Methods: A retrospective, causal longitudinal inverse probability of treatment weighted analysis was conducted to compare OS between patients initiating apalutamide or enzalutamide between December 2019 and December 2023 using de-identified linked US clinical and insurance claims data.

Overall survival in patients with metastatic castration-sensitive prostate cancer treated with apalutamide versus abiraterone acetate: a head-to-head analysis of real-world patients in the USA.

Head-to-head studies of survival outcomes associated with different androgen receptor pathway inhibitor (ARPI) treatments for metastatic castration (hormone)-sensitive prostate cancer have not been conducted. The purpose of this study was to compare 24-month overall survival among ARPI-naive patients with metastatic castration-sensitive prostate cancer (mCSPC) who initiated apalutamide or abiraterone acetate. Linked de-identified clinical and claims healthcare databases were used to compare overall survival between patients with mCSPC initiating apalutamide or abiraterone acetate treated in community-based urology practices in the USA.

Enzalutamide and Prostate-Specific Antigen Levels in Metastatic Prostate Cancer: A Secondary Analysis of the ARCHES Randomized Clinical Trial.

Importance: In men with metastatic hormone-sensitive prostate cancer (mHSPC), prostate-specific antigen (PSA) decline after treatment has been associated with improved survival. However, the data on PSA decline are limited in men with mHSPC after treatment with enzalutamide plus androgen deprivation therapy (ADT).

Objective: To evaluate the association of enzalutamide plus ADT in men with mHSPC by PSA level at study enrollment in individuals with prior ADT and by degree of PSA reduction with clinical end points.

On the Horizon: A Global Multidisciplinary Perspective on Delivering Emerging Therapies for Patients with BCG-Naïve High-Risk NMIBC.

Patients with high-risk non-muscle invasive bladder cancer (NMIBC) are generally treated with transurethral resection of the bladder tumor followed by intravesical bacillus Calmette-Guérin (BCG), the current standard of care. However, recurrence or progression is common and may result in patients requiring radical cystectomy. Additionally, BCG continues to be in short supply worldwide.

First-line talazoparib plus enzalutamide versus placebo plus enzalutamide in men with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: patient-reported outcomes from the randomised, double-blind, placebo-controlled, phase 3 TALAPRO-2 trial.

Background: In the phase 3 TALAPRO-2 trial, talazoparib plus enzalutamide significantly improved radiographic progression-free survival compared with placebo plus enzalutamide in men with metastatic castration-resistant prostate cancer harbouring alterations in genes involved in homologous recombination repair (HRR). We aimed to assess patient-reported outcomes in patients with HRR-deficient metastatic castration-resistant prostate cancer in TALAPRO-2.

Methods: TALAPRO-2 is a randomised, double-blind, placebo-controlled, phase 3 trial conducted at 223 hospitals, cancer centres, and medical centres in 26 countries worldwide.

First-line talazoparib plus enzalutamide versus placebo plus enzalutamide for metastatic castration-resistant prostate cancer: patient-reported outcomes from the randomised, double-blind, placebo-controlled, phase 3 TALAPRO-2 trial.

Background: Patients with metastatic castration-resistant prostate cancer have poor prognoses, underscoring the need for novel therapeutic strategies. First-line talazoparib plus enzalutamide significantly improved radiographic progression-free survival compared with placebo plus enzalutamide in men with metastatic castration-resistant prostate cancer in the phase 3 TALAPRO-2 study. We aimed to evaluate patient-reported outcomes in the all-comers cohort of TALAPRO-2, which included patients with and without alterations in homologous recombination repair (HRR) genes.

Darolutamide plus androgen-deprivation therapy: propensity score matching of ARASEC and historic clinical trial patients.

Darolutamide plus androgen-deprivation therapy (ADT) with docetaxel is one of the standards of care for metastatic hormone-sensitive prostate cancer (mHSPC), based on the phase III ARASENS study. To provide the option to use darolutamide without docetaxel to meet patients' needs and preferences, the phase III placebo-controlled ARANOTE study was undertaken. Reflecting evolving treatment guidelines for mHSPC, the complementary US-based ARASEC study was designed with a single, prospectively-enrolled investigational arm (darolutamide plus ADT) and an ADT monotherapy arm derived from the previous phase III CHAARTED study.

Enzalutamide in biochemically recurrent prostate cancer: key findings from the EMBARK study.

This podcast features two of the investigators from the international, randomized, phase 3 EMBARK trial (NCT02319837) in conversation. EMBARK evaluated the efficacy and safety of enzalutamide plus androgen deprivation therapy and enzalutamide monotherapy, as compared with androgen deprivation therapy alone, in patients with nonmetastatic castration-sensitive prostate cancer and biochemical recurrence at high risk for metastasis. In this podcast, the second in the EMBARK series, the speakers discuss the key efficacy and safety findings from the trial, consider some of the patient-reported outcomes and their implications for quality of life, and review some of the implications for clinical practice.

Enzalutamide in patients with high-risk biochemically recurrent prostate cancer according to the European Association of Urology definition: a post hoc analysis of EMBARK.

High-risk biochemical recurrence (BCR) definition varies across clinical studies/practice guidelines. We evaluated metastasis-free survival (MFS) by blinded, independent, central review and safety in EMBARK (NCT02319837) patients defined as high-risk BCR per European Association of Urology (EAU) criteria. Patients post-radical prostatectomy (prostatic-specific antigen doubling time ≤9 months) or post-radiation therapy with a Gleason score > 7, were considered EAU high-risk.

Enzalutamide in biochemically recurrent prostate cancer: design and rationale of the EMBARK study.

This podcast features two of the investigators from the international, randomized, phase III EMBARK trial (NCT02319837) in conversation. The findings from EMBARK led to the subsequent approval of enzalutamide by the US Food and Drug Administration for nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence (BCR) at high risk for metastasis, and by the European Medicines Agency for patients with high-risk BCR nmCSPC who are unsuitable for salvage radiotherapy. Treatment guidelines have now been updated accordingly to reflect these approvals.

Microultrasonography-Guided vs MRI-Guided Biopsy for Prostate Cancer Diagnosis: The OPTIMUM Randomized Clinical Trial.

Importance: High-resolution microultrasonography-guided biopsy is an alternative to MRI fusion-guided biopsy for prostate cancer diagnosis.

Objective: To compare microultrasonography-guided and MRI fusion-guided biopsy.

Design, Setting, And Participants: A multicenter, international, open-label, randomized, noninferiority trial of biopsy-naive men from 20 centers (8 countries) with clinical suspicion of prostate cancer (elevated prostate-specific antigen [PSA] and/or abnormal digital rectal examination findings) from December 2021 to September 2024.