Efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer (GENESIS): protocol for a multicentre, open-label, single-arm clinical trial

Efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer (GENESIS): protocol for a multicentre, open-label, single-arm clinical trial

Introduction This is a multicentre, open-label, single-arm clinical trial to evaluate the efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer.Methods and analysis The trial will be performed at 4 university hospitals and 14 city hospitals in Japan. The...

Full description

Bibliographic Details
Main Authors:	Masato Fujisawa, Kenichi Harada, Yasumasa Kakei, Hideaki Miyake, Yuzo Nakano, Tomoaki Terakawa, Keiko Miyakoda
Format:	Article
Language:	English
Published:	BMJ Publishing Group 2023-03-01
Series:	BMJ Open
Online Access:	https://bmjopen.bmj.com/content/13/3/e070173.full

Similar Items

Apalutamide: Emerging Therapy for Non-Metastatic Castration-Resistant Prostate Cancer
by: Nora A. Alkhudair
Published: (2019-03-01)

Treatment of non-metastatic castration-resistant prostate cancer: focus on apalutamide
by: Gul A, et al.
Published: (2019-08-01)

The earlier the better? Apalutamide for non-metastatic castration resistant prostate cancer
by: Maria De Santis, et al.
Published: (2019-04-01)

Association between sarcopenia based on psoas muscle index and the response to nivolumab in metastatic renal cell carcinoma: A retrospective study
by: Hideto Ueki, et al.
Published: (2022-07-01)

Apalutamide for metastatic castration-sensitive prostate cancer: final analysis of the Asian subpopulation in the TITAN trial
by: Byung Ha Chung, et al.
Published: (2023-01-01)

Apalutamide in the treatment of castrate-resistant prostate cancer: evidence from clinical trials
by: Vadim S. Koshkin, et al.
Published: (2018-12-01)

Sequential therapy with darolutamide in patients with non‐metastatic castration‐resistant prostate cancer resistant to enzalutamide or apalutamide
by: Saizo Fujmoto, et al.
Published: (2023-02-01)

Cine magnetic resonance imaging predicts thrombus adhesion in metastatic renal cell carcinoma with an inferior vena cava tumor thrombus: A case of pathological complete response with pembrolizumab plus lenvatinib
by: Takuto Hara, et al.
Published: (2024-01-01)

Impact of penile rehabilitation with low-dose vardenafil on recovery of erectile function in Japanese men following nerve-sparing radical prostatectomy
by: Yuzo Nakano, et al.
Published: (2014-12-01)

Apalutamide for prostate cancer: Multicentre and multidisciplinary real‐world study of 227 patients
by: Julián Córdoba Sánchez, et al.
Published: (2023-12-01)

Pathological complete response of renal cell carcinoma with vena cava tumor thrombus to neoadjuvant TKI/IO combination therapy
by: Takuto Hara, et al.
Published: (2021-11-01)

The LACOG-0415 phase II trial: abiraterone acetate and ADT versus apalutamide versus abiraterone acetate and apalutamide in patients with advanced prostate cancer with non-castration testosterone levels
by: Gustavo Werutsky, et al.
Published: (2019-05-01)

Cine magnetic resonance imaging in evaluating retroperitoneal leiomyosarcoma arising from the inferior vena cava
by: Taisuke Tobe, et al.
Published: (2024-01-01)

Apalutamide, Darolutamide and Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC): A Critical Review
by: Carlo Cattrini, et al.
Published: (2022-03-01)

The ARAMIS trial: Why Darolutamide is better than apalutamide and enzalutamide in nonmetastatic castration-resistant prostate cancer
by: Sambit Tripathy
Published: (2021-01-01)

Real-world burden of adverse events for apalutamide- or enzalutamide-treated non-metastatic castration-resistant prostate cancer patients in the United States
by: Arif Hussain, et al.
Published: (2022-03-01)

Apalutamide-induced ichthyosiform eruption
by: Christian Ciolfi, et al.
Published: (2023-08-01)

Interstitial lung disease induced by apalutamide therapy for castration‐resistant prostate cancer: A report of a rare case
by: Fumiaki Kirishima, et al.
Published: (2022-05-01)

Apalutamide-Induced Toxic Epidermal Necrolysis in a Caucasian Patient with Metastatic Castration-Sensitive Prostate Cancer: A Case Report and Review of the Literature
by: Calvin R. Flynn, et al.
Published: (2023-08-01)

Robot‐assisted laparoscopic pyeloplasty in the management of lower pole ureteropelvic junction obstruction in a patient with an incomplete duplicated collecting system
by: Hideto Ueki, et al.
Published: (2023-11-01)

Editorial Comment to Interstitial lung disease induced by apalutamide therapy for castration‐resistant prostate cancer: A report of a rare case
by: Takeshi Yuasa
Published: (2022-05-01)

Psoriatic Skin Lesions after Apalutamide Treatment
by: Fumi Miyagawa, et al.
Published: (2022-02-01)

Docetaxel, abiraterone, enzalutamide, apalutamide in patients with metastatic hormone-sensitive prostate cancer
by: Harkirat Singh Talwar
Published: (2021-01-01)

Real-world prostate-specific antigen reduction and survival outcomes of metastatic hormone-sensitive prostate cancer patients treated with apalutamide: An observational, retrospective, and multicentre study
by: Alicia López-Abad, et al.
Published: (2024-03-01)

Apalutamide versus bicalutamide in combination with androgen deprivation therapy for metastatic hormone sensitive prostate cancer
by: Takashi Ueda, et al.
Published: (2024-01-01)

Application of hyaluronic acid/carboxymethyl cellulose membrane for early continence after nerve-sparing robot-assisted radical prostatectomy
by: Nobuyuki Hinata, et al.
Published: (2019-04-01)

Prognostic significance of time to castration resistance in patients with metastatic castration-sensitive prostate cancer
by: Y. Matsushita, et al.
Published: (2020-07-01)

Efficacy and safety of apalutamide in Japanese patients with nonmetastatic castration-resistant prostate cancer: a subgroup analysis of a randomized, double-blind, placebo-controlled, Phase-3 study
by: Hiroji Uemura, et al.
Published: (2020-12-01)

[Translated article] RF-Adverse Skin Reaction to Apalutamide: An Emerging Effect
by: M. Pons Benavent, et al.
Published: (2023-04-01)

Apalutamide for patients with metastatic castrationsensitive prostate cancer in East Asia: a subgroup analysis of the TITAN trial
by: Byung Ha Chung, et al.
Published: (2022-01-01)

Case report: Apalutamide-induced severe lethal cutaneous adverse effects in China
by: Qi Wang, et al.
Published: (2024-01-01)

An oral cancer vaccine using Bifidobacterium vector augments combination of anti-PD-1 and anti-CTLA-4 antibodies in mouse renal cell carcinoma model
by: Hideto Ueki, et al.
Published: (2023-06-01)

Acute generalized exanthematous pustulosis during apalutamide treatment in a patient with prostate cancer
by: Tomoko Honda, et al.
Published: (2022-11-01)

Apalutamide‐associated skin rash in patients with prostate cancer: Histological evaluation by skin biopsy
by: Yoichiro Tohi, et al.
Published: (2021-09-01)

Abigene, a Prospective, Multicentric Study of Abiraterone Acetate Pharmacogenetics in Metastatic Castration-Resistant Prostate Cancer
by: Jean-Marc Ferrero, et al.
Published: (2023-02-01)

Apalutamide (APA) for metastatic castration-sensitive prostate cancer (mCSPC) in TITAN: Outcomes in patients (pts) with de novo (D1) mCSPC vs. progression to mCSPC after localized disease (D0) at diagnosis
by: A.S. Bjartell, et al.
Published: (2020-07-01)

Significance of preoperatively observed detrusor overactivity as a predictor of continence status early after robot-assisted radical prostatectomy
by: Akihiro Yanagiuchi, et al.
Published: (2014-12-01)

TREATMENT OF PATIENTS WITH THE CYCLE OF THE SUPERMONTAL ARM OF THE ONTOGENIC GENESIS
by: Mohammed Rezmak, et al.
Published: (2019-04-01)

Targeting Metabolic Vulnerabilities to Overcome Prostate Cancer Resistance: Dual Therapy with Apalutamide and Complex I Inhibition
by: Valentin Baumgartner, et al.
Published: (2023-11-01)

Context-Specific Efficacy of Apalutamide Therapy in Preclinical Models of <i>Pten</i>-Deficient Prostate Cancer
by: Marco A. De Velasco, et al.
Published: (2021-08-01)