Background: Worldwide, prostate cancer (PC) is the second most diagnosed cancer and the fifth leading cause of cancer death in men. Hormonal therapies, commonly used for PC, are associated with a range of treatment-emergent adverse events (TEAEs). The population from Japan seems to be at higher risk of developing TEAEs of skin rash compared to the overall global population.
View Article and Find Full Text PDFBackground: Abiraterone acetate plus prednisone with androgen deprivation therapy is a standard treatment option for patients with high-risk metastatic castration-sensitive prostate cancer (mCSPC). However, no data are available on the optimal subsequent treatment option in patients treated with abiraterone acetate plus prednisone for high-risk mCSPC.
Objective: We aimed to compare the clinical outcomes of subsequent therapy after discontinuation of abiraterone acetate plus prednisone in patients with high-risk mCSPC.
Objective: The prognosis of high-risk metastatic hormone-naïve prostate cancer is poor, and real-world evidence of therapeutic options and sequences is lacking. The J-ROCK study aimed to evaluate the outcomes in a real-world setting in Japan.
Methods: Patients with high-risk metastatic hormone-naïve prostate cancer diagnosed after May 2019 were eligible.
Objective: To assess the correlation between PFS2 and OS among patients with advanced prostate cancer (PC) in a real-world setting for Japan.
Methods: This was a retrospective analysis using the Japanese MDV database. Patients with nmCRPC (non-metastatic Castration-Resistant PC), mCRPC (metastatic Castration-Resistant PC), and mCNPC (metastatic Castration-Naïve PC) were identified and their medical records were investigated for PFS2 and death.
Background: In the LATITUDE study (ClinicalTrials.gov, NCT01715285), compared with placebos, abiraterone acetate plus prednisone (AAP) with androgen deprivation therapy (ADT) provided significant overall survival (OS) benefit in high-risk metastatic castration-sensitive prostate cancer (mCSPC) patients. It is controversial whether survival benefits would remain if all patients in the placebo group subsequently received life-extending therapies.
View Article and Find Full Text PDFBackground: Abiraterone acetate plus prednisolone is approved to treat patients with castration-resistant prostate cancer. This study evaluated the safety and efficacy of abiraterone acetate plus prednisolone in castration-resistant prostate cancer patients with or without previous chemotherapy in a real-world setting in Japan.
Methods: This study was an observational, prospective, post-marketing surveillance.
An amendment to this paper has been published and can be accessed via the original article.
View Article and Find Full Text PDFBackground: A higher incidence of apalutamide-related skin rash has been observed in Japanese patients with prostate cancer (PC).
Methods: This integrated analysis of data of Japanese patients from 2 global Phase 3 studies, SPARTAN ( NCT01946204 ; patients with non-metastatic castration-resistant PC [nmCRPC]) and TITAN ( NCT02489318 ; patients with metastatic castration-sensitive PC [mCSPC]), and the Phase 1 study 56021927PCR1008 ( NCT02162836 ; patients with metastatic CRPC [mCRPC]), assessed clinical risk factors of apalutamide-related skin rash as well as the potential correlation with plasma exposure to apalutamide. Kaplan-Meier method was used for time-to-event analyses.
Several recent randomized controlled trials (RCTs) in non-metastatic castration resistant prostate cancer (nmCRPC) have demonstrated a significant improvement in metastasis-free survival (MFS); however, an improvement in overall survival (OS) is not reported yet. Since the surrogacy of MFS to OS has not been formally investigated in nmCRPC in Japan, this study evaluated the correlation between MFS and OS among a nmCRPC population in Japan. This is a retrospective longitudinal observational cohort study in patients with nmCRPC using the Japanese Medical Data Vision (MDV) database covering over 20 million patients.
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