Clinical trial NCT03520478: A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer
Official title: A Phase III, Multicenter, Randomized, Open Study of SHR3680 Compared to Bicalutamide in the Treatment of Patients With Hormone Sensitive Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prostate Cancer
Hormone-Dependent Prostate Cancer
Keywords: Hormone sensitive prostate cancer
SHR3680
Anti-androgen receptor
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-05-09
Enrollment: 654
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the safety and efficacy of SHR3680 with bicalutamide in the treatment of patients with hormone sensitive prostate cancer.

Detailed description: This is an open, multicenter, randomized phase III trial. This clinical study compares the efficacy and safety of SHR3680 with bicalutamide in the patients with hormone sensitive prostate cancer. Approximately 572 patients who meet the entry criteria will be randomly assigned in a 1:1 ratio to SHR3680 or bicalutamide treatment. Primary endpoints of the study are radiological progress-free survival (rPFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* Age≧18 year, male;
* ECOG performance scale 0 to 1;
* Histologically or cytological confirmed prostate adenocarcinoma without neuroendocrine differentiation or small cell features ;
* Adequate hepatic, renal, heart, and hematological functions;
* Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

* Subject has received any prior radiation therapy or surgery for prostate cancer, except 1 course of palliative surgical therapy if it was used at least 4 weeks prior to day 1;
* Previous use or are using a second-generation androgen receptor antagonist (enzalutamide, ARN-509, ODM-201), abiraterone, ketoconazole for prostate cancer, or other agents that will inhibit the production of androgens;
* Have participated in an interventional clinical trial or been treated with the following drugs in the past 4 weeks prior to day 1: 5-alpha reductase inhibitors, estrogen, progestin, and herbal products known to decrease PSA levels ;
* Evidence of brain metastasis or primary tumors;
* Planned to initiate any other anti-tumor therapies during the study;
* Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption; Clinically significant cardiovascular diseases;
* History of seizure or certain conditions that may predispose to seizure;
* Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.

Primary outcomes:
measure: rPFS
timeFrame: Approximately 70 months
measure: OS
timeFrame: Approximately 70 months
Secondary outcomes:
measure: Time to prostate specific antigen (PSA) progression
timeFrame: Approximately 70 months
measure: Time to skeletal-related events
timeFrame: Approximately 70 months
measure: Objective response rate (ORR)
timeFrame: Approximately 70 months
measure: Time to initiation of a new antineoplastic therapy
timeFrame: Approximately 70 months
Other outcomes:
Locations:
city: Burgas
country: Bulgaria
facility: Complex oncological center - Bourgas
city: Burgas
country: Bulgaria
facility: UMHAT 'Deva Maria'. EOOD
city: Dobrich
country: Bulgaria
facility: MHAT - Dobrich. AD
city: Gabrovo
country: Bulgaria
facility: MHAT 'Dr. Tota Venkova'. AD
city: Plovdiv
country: Bulgaria
facility: Complex Oncological Center - Plovdiv. EOOD
city: Plovdiv
country: Bulgaria
facility: MHAT 'Central Onco Hospital'. OOD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital Ead
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: The third hospital of Peking University
city: Beijing
country: China
facility: Tumor Hospital of the Chinese Academy of Medical Sciences
city: Changchun
country: China
facility: China Japan Friendship Hospital of Jilin University
city: Changchun
country: China
facility: The first hospital of Jilin University
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Chongqing
country: China
facility: Army characteristic medical center of the Chinese people's Liberation Army
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Chongqing
country: China
facility: The First Affiliated Hospital of Army Medical University
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: Sun Yat-Sen hospital of Sun Yat-Sen University
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University Medicine college
city: Hangzhou
country: China
facility: The Second affiliated hospital of zhejiang university medical college
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Hangzhou
country: China
facility: Zhejiang Province People's Hospital
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Kunming
country: China
facility: Yunnan Provincial Cancer Hospital
city: Lanzhou
country: China
facility: The second hospital of Lanzhou University
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Gulou Hospital Affiliated to Medical College of Nanjing University
city: Nanjing
country: China
facility: Jiangsu Provincial Cancer Hospital
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
city: Shanghai
country: China
facility: Huadong Hospital of Fudan University
city: Shanghai
country: China
facility: Ruijin Hospital
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Shanghai
country: China
facility: The Cancer Hospital of Fudan University
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
city: Shenyang
country: China
facility: Liaoning Provincial Cancer Hospital
city: Shijia Zhuang
country: China
facility: The fourth hospital of Hebei Medical University
city: Tianjing
country: China
facility: The second hospital of Tianjin Medical University
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: Hubei Provincial Cancer Hospital
city: Wuhan
country: China
facility: Tongji Hospital, Tongji medical college of HUST
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical college of HUST
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Yangzhou
country: China
facility: Jiangsu Subei people's Hospital
city: Zhengzhou
country: China
facility: Henan people's Hospital
city: Zhengzhou
country: China
facility: Henan Provincial Cancer Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Plzen
country: Czechia
facility: RESEARCH SITE s.r.o.
state: Plzeň
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Pavlov
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha
country: Czechia
facility: Nemocnice Na Homolce
city: Ústí Nad Labem
country: Czechia
facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
city: Bielsko-Biala
country: Poland
facility: Beskidzkie Centrum Onkologii im.Jana Pawla II
state: Bielsko-Biała
city: Wesoła
country: Poland
facility: LexMedica Osrodek Badan Klinicznych
state: Weigla
city: Biała Podlaska
country: Poland
facility: KO-MED Centra Kliniczne Biala Podlaska
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii
city: Piotrków Trybunalski
country: Poland
facility: Provita Profamilia
city: Słupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka
Study officials:
affiliation: Fudan University
name: Dingwei Ye, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gu W, Han W, Luo H, Zhou F, He D, Ma L, Guo H, Liang C, Chong T, Jiang J, Chen Z, Wang Y, Zou Q, Tian Y, Xiao J, Huang J, Zhu S, Dong Q, Zhang X, Li H, Yang X, Chen C, Li J, Jin C, Zhang X, Ye D; CHART Investigators. Rezvilutamide versus bicalutamide in combination with androgen-deprivation therapy in patients with high-volume, metastatic, hormone-sensitive prostate cancer (CHART): a randomised, open-label, phase 3 trial. Lancet Oncol. 2022 Oct;23(10):1249-1260. doi: 10.1016/S1470-2045(22)00507-1. Epub 2022 Sep 5.