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A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03520478
Collaborator
(none)
654
Enrollment
67
Locations
2
Arms
83
Anticipated Duration (Months)
9.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
654 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III, Multicenter, Randomized, Open Study of SHR3680 Compared to Bicalutamide in the Treatment of Patients With Hormone Sensitive Prostate Cancer
Actual Study Start Date :
May 30, 2018
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Apr 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: SHR3680

Participants will receive SHR3680 orally

Drug: SHR3680
Tablet. Specifications of 80 mg; orally, once a day
Active Comparator: bicalutamide

Participants will receive bicalutamide orally

Drug: Bicalutamide
Tablet. Specifications of 50 mg; orally, once a day

Outcome Measures

Primary Outcome Measures

  1. rPFS [Approximately 70 months]

    Time from randomisation to radiologically confirmed progressive disease or death due to any cause

  2. OS [Approximately 70 months]

    Time from randomisation to death due to any cause

Secondary Outcome Measures

  1. Time to prostate specific antigen (PSA) progression [Approximately 70 months]

    Time from randomisation to the first time of PSA progression according to the criterion of PCGW3

  2. Time to skeletal-related events [Approximately 70 months]

    Time from randomisation to the first occurrence of a fracture or treatment for the fracture. The skeletal-related event is defined as the occurrence of either pathological or clinical fracture, spinal cord compression, bone-related radiotherapy or surgery

  3. Objective response rate (ORR) [Approximately 70 months]

    The percentage of subjects with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

  4. Time to initiation of a new antineoplastic therapy [Approximately 70 months]

    Time from randomisation to the initiation of antineoplastic subsequent to the study treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Complex oncological center - Bourgas Burgas Bulgaria
2 UMHAT 'Deva Maria'. EOOD Burgas Bulgaria
3 MHAT - Dobrich. AD Dobrich Bulgaria
4 MHAT 'Dr. Tota Venkova'. AD Gabrovo Bulgaria
5 Complex Oncological Center - Plovdiv. EOOD Plovdiv Bulgaria
6 MHAT 'Central Onco Hospital'. OOD Plovdiv Bulgaria
7 Acibadem City Clinic Tokuda Hospital Ead Sofia Bulgaria
8 Affiliated Hospital of Hebei University Baoding China
9 Beijing Cancer Hospital Beijing China
10 Beijing Friendship Hospital, Capital Medical University Beijing China
11 Peking Union Medical College Hospital Beijing China
12 The third hospital of Peking University Beijing China
13 Tumor Hospital of the Chinese Academy of Medical Sciences Beijing China
14 China Japan Friendship Hospital of Jilin University Changchun China
15 The first hospital of Jilin University Changchun China
16 Hunan Cancer Hospital Changsha China
17 West China Hospital of Sichuan University Chengdu China
18 Army characteristic medical center of the Chinese people's Liberation Army Chongqing China
19 Chongqing Cancer Hospital Chongqing China
20 The First Affiliated Hospital of Army Medical University Chongqing China
21 The First Affiliated Hospital of Fujian Medical University Fuzhou China
22 Sun Yat-Sen hospital of Sun Yat-Sen University Guangzhou China
23 Sun Yat-sen University Cancer Center Guangzhou China
24 The First Affiliated Hospital of Zhejiang University Medicine college Hangzhou China
25 The Second affiliated hospital of zhejiang university medical college Hangzhou China
26 Zhejiang Cancer Hospital Hangzhou China
27 Zhejiang Province People's Hospital Hangzhou China
28 Anhui Provincial Hospital Hefei China
29 The First Affiliated Hospital of Anhui Medical University Hefei China
30 Qilu Hospital of Shandong University Jinan China
31 Yunnan Provincial Cancer Hospital Kunming China
32 The second hospital of Lanzhou University Lanzhou China
33 The First Affiliated Hospital of Nanchang University Nanchang China
34 Gulou Hospital Affiliated to Medical College of Nanjing University Nanjing China
35 Jiangsu Provincial Cancer Hospital Nanjing China
36 Jiangsu Provincial People's Hospital Nanjing China
37 Huadong Hospital of Fudan University Shanghai China
38 Ruijin Hospital Shanghai China
39 Shanghai General Hospital Shanghai China
40 The Cancer Hospital of Fudan University Shanghai China
41 Zhongshan Hospital of Fudan University Shanghai China
42 Liaoning Provincial Cancer Hospital Shenyang China
43 The fourth hospital of Hebei Medical University Shijia Zhuang China
44 The second hospital of Tianjin Medical University Tianjing China
45 The First Affiliated Hospital of Wenzhou Medical University Wenzhou China
46 Hubei Provincial Cancer Hospital Wuhan China
47 Tongji Hospital, Tongji medical college of HUST Wuhan China
48 Union Hospital, Tongji Medical college of HUST Wuhan China
49 Wuxi People's Hospital Wuxi China
50 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an China
51 The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an China
52 The First Affiliated Hospital of Xiamen University Xiamen China
53 Jiangsu Subei people's Hospital Yangzhou China
54 Henan people's Hospital Zhengzhou China
55 Henan Provincial Cancer Hospital Zhengzhou China
56 The First Affiliated Hospital of Zhengzhou University Zhengzhou China
57 RESEARCH SITE s.r.o. Plzen Plzeň Czechia
58 Fakultni nemocnice u sv. Anny v Brne Brno Czechia
59 Fakultni nemocnice Olomouc Pavlov Czechia
60 Nemocnice Na Homolce Praha Czechia
61 Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z. Ústí Nad Labem Czechia
62 Beskidzkie Centrum Onkologii im.Jana Pawla II Bielsko-Biala Bielsko-Biała Poland
63 LexMedica Osrodek Badan Klinicznych Wesoła Weigla Poland
64 KO-MED Centra Kliniczne Biala Podlaska Biała Podlaska Poland
65 Swietokrzyskie Centrum Onkologii Kielce Poland
66 Provita Profamilia Piotrków Trybunalski Poland
67 Wojewodzki Szpital Specjalistyczny im. J. Korczaka Słupsk Poland

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: Dingwei Ye, M.D., Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03520478
Other Study ID Numbers:
  • SHR-3680-III-HSPC
First Posted:
May 9, 2018
Last Update Posted:
Mar 2, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.
Hormone sensitive prostate cancer
SHR3680
Anti-androgen receptor
Additional relevant MeSH terms:
Prostatic Neoplasms
Hypersensitivity
Bicalutamide

Study Results

No Results Posted as of Mar 2, 2021